Product Recalls and Safety Information
If there are any diabetes product recalls or safety notices that could affect our patient population, it will be posted below along with any relevant links for further information. Be sure to sign up for our newsletter to receive any safety alerts from our Pediatric Diabetes Team.
Voluntary Recall of VariSoft Infusion Sets for Tandem Diabetes Pump Users
Tandem Diabetes Care has issued a voluntary recall notice for a limited number of VariSoft infusion sets manufactured by ConvaTec/Unomedical, used with Tandem pumps. The recall is due to the connector detaching more easily than expected, potentially interrupting insulin delivery. Users are urged to check lot numbers, follow instructions in Tandem's email or letter, and return affected sets. The FAQs provide details on required actions, potential risks, and contacts for support. Continue reading below for more information.
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This voluntary recall is for a limited number of VariSoft infusion sets with the following lot numbers: 5388367; 5388357; 5388371; 5388362; 5388368; 5388366; 5388372; 5388376.
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What is the issue?
The infusion set manufacturer, ConvaTec/Unomedical, has found that in rare cases the VariSoft infusion set connector detaches more easily from the infusion set than expected, requiring less force to disconnect than intended, and thereby interrupting the delivery of insulin.
What does this mean?
Please take the following action:
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Compare the lot numbers of any VariSoft infusion sets in your possession to the affected lot numbers listed above.
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Look for an email or letter from Tandem. It will include more information on why a few VariSoft infusion sets are being recalled and the steps patients should take.
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To learn more about this voluntary recall and potential implications for your patients, please read the frequently asked questions below or refer to the official voluntary recall notice.
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Frequently Asked Questions (FAQS)
1. What action is Tandem requesting of me?
Regulatory requirements ask that you immediately read the official voluntary recall notice. It will include instructions for how you and your patients can check inventories, acknowledge receipt of this Recall Notice, and initiate the return of any affected infusion sets that you may have in your possession. Once we receive the required information, we will ship your replacement products. Alternatively, you can call Tandem Customer Technical Support at 1-877-801-6901.
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2. Can patients use a VariSoft infusion set affected by the recall?
No, you should not use a VariSoft infusion set affected by the recall. Please notify Tandem that you have affected VariSoft infusion sets in your possession by phone at 1-877-801-6901. A Tandem Customer Technical Support Specialist will assist you with a return of the affected infusion sets and replacement with new infusion sets.
3. Do patients need to return any VariSoft products back to Tandem?
Yes, please follow the instructions provided by a Tandem Customer Technical Support Specialist to return any VariSoft infusion sets belonging to the affected lot numbers.
4. If a patient accidentally uses an affected VariSoft infusion set, what is the risk?
In rare cases the VariSoft infusion set connector detaches more easily from the infusion set than expected, requiring less force to disconnect than intended, and thereby interrupting the delivery of insulin. Risks include:
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Hazard: Disconnected tubing from the infusion set.
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Hazardous Situation: Disconnection occurring during sleep where it is not detected, leading to missed basal dosing during sleep.
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Harm: Elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
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Immediate consequences: Transient and marginally higher blood glucose level than intended.
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Long-range consequences: High blood glucose and ketone levels leading to diabetic ketoacidosis.
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Long-term consequences: Risk of ketoacidosis-related sequela.
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Children with increased nighttime movement activity may be more at risk but are presumed to be closely monitored by a guardian (caregiver). Patients who are critically ill or suffer from an infection are more at risk of rising blood sugar and ketone levels, but it is presumed that they take extra precautions suitable for their individual situation.
5. Why is this voluntary recall being issued?
Unomedical’s and Tandem’s top priority is our customers' safety and providing the highest level of support. Unomedical issued the Voluntary Recall Notice in full transparency to ensure that customers are aware of the potential risks of using VariSoft infusion sets from the affected lots and to facilitate sending you replacement infusion sets from unaffected lot numbers.
6. Who do I contact if I have more questions?
U.S customers can email Techsupport@tandemdiabetes.com or call Tandem Diabetes Care Customer Support at 1-877-801-6901. Our team is available 24/7/365. Customers outside the US or Canada can contact their local authorized Tandem distributor.
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Omnipod 5 Bolus Calculator Issue
There is a voluntary Medical Device Correction related to the Omnipod® 5 App on Google Play for compatible Android smartphones, part of the Omnipod 5 Automated Insulin Delivery System. Two adverse events have been reported concerning an issue with the app's bolus calculator.
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This correction specifically involves the Omnipod 5 App and not the Omnipod 5 Controllers, Omnipod 5 Pods, Omnipod® DASH Insulin Management System, or Omnipod® Insulin Management System.
The issue arises when using the bolus calculator to enter a bolus dose with a value less than 1 unit, starting with a decimal point. The calculator may fail to record the decimal point, potentially leading to the delivery of more insulin than intended, causing severe hypoglycemia.
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To avoid this, users are advised to always enter a zero before the decimal when changing a bolus dose to less than 1 unit, double-check the bolus amount before confirming, and monitor the amount during the bolus delivery process. The Omnipod 5 App will deliver the confirmed amount shown on the Confirm Bolus screen.
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While this is a voluntary action, it is safe to continue using the Omnipod 5 App if users follow the recommended steps. The correction is being carried out in cooperation with the U.S. Food and Drug Administration (FDA). If you have any questions regarding the information provided in this Medical Device Correction, please call 1-800-591-3455 to speak with a member of the Insulet Customer Care team who are available 24 hours a day, 7 days a week.
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Insulet Omnipod 5 Controller Charging Issues
Insulet has announced an important safety issue related to the Omnipod® 5 Controller. Insulet has received 24 reports of an issue with the Omnipod® 5 Controller charging port and cable, including the cable melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port. The excess heat may cause minor burns if those areas of the device are touched or could lead to fire.
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Monitor your Omnipod® 5 Controller for the following issues:
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The Controller charge port or charging cable appears to be melted, deformed, or discolored.
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The Controller experiences overheating (making it uncomfortable to hold) or emits an odor while charging.
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If you experience any of the issues listed above, disconnect the charger from the power outlet and do NOT charge the Omnipod® 5 Controller. This would result in the Omnipod® 5 Controller failing to charge which would require you to switch to your backup insulin plan. Then, promptly contact Insulet’s dedicated Customer Care team at 1-800-641-2049 to request a replacement device. If you have a compatible Android smartphone (see omnipod.com/compatibility), you may want to switch to using the Omnipod® 5 App on your smartphone.
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If you are NOT experiencing any of the issues above, you can continue using your Omnipod® 5 Controller. Insulet recommends that you consistently follow the actions below to reduce the risk of the Omnipod® 5 Controller charging port issue:
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Monitor your Omnipod® 5 Controller while it is charging for signs of melting, deforming, discoloring, or an odor. If this happens, disconnect the charger from the power outlet and contact Insulet’s Customer Care team at 1-800-641-2049. DO NOT charge unattended.
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When charging, ensure your Omnipod® 5 Controller is placed on a flat, heat resistant surface, is not covered, and is not in an enclosed space.
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Always inspect your Omnipod® 5 Controller charging port and cable before charging for any signs of damage or discoloration. If you see signs of damage or discoloration, do not charge the device, and contact Insulet’s Customer Care team at 1-800-641-2049.
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Always inspect your Omnipod® 5 Controller charging port and cable for any debris before charging. If you see debris, use canned compressed air (electronic duster) to clean it out. Never blow air into the charging port or cable with your mouth or use hard, sharp objects to clean it.
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Take care when plugging and unplugging your charging cable. Do not force or bend the end of the charging cable into the Omnipod® 5 Controller charging port.
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Only use the charging cable and power adapter that came with your Omnipod® 5 Controller. Contact Insulet’s Customer Care team at 1-800-641-2049 if you need an Omnipod® 5 charging cable and power adapter.
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Do not charge your device for longer than is needed (for example, disconnect the Omnipod® 5 Controller once it reaches 100% charge)
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For more information visit omnipod.com/fsn-11-2022.
Medtronic MiniMed 600 and 700 Series Pump Battery Cap Issues
Medtronic has announced a potential issue with MiniMed™ 600 and 700 series insulin pumps relating to the battery cap on the pump. If the metal contact on the battery cap becomes loose or falls off, it can result in an incomplete battery connection, leading to no power source to the pump.
When the pump detects no power source, an "Insert Battery" alarm will occur, and insulin delivery will immediately be stopped. After 10 minutes, the alarm sound may increase to a siren, and the pump will turn off. If the pump stops insulin delivery due to power loss, this could lead to high blood sugar and possibly diabetic ketoacidosis (DKA).
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Please notify Medtronic of any adverse events that you think are related to your insulin pump or if the metal contact on your pump's battery cap is damaged by calling the Medtronic 24-hour Technical Support Line at 877-496-7933.
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Adverse events or quality problems with MiniMed™ 600 and 700 series insulin pumps can also be reported to the FDA's MedWatch Adverse Event Reporting Program online at fda.gov/medwatch/report.htm​.
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For more information, including how to check your pump's battery cap and what to do if you think it is damaged, visit medtronicdiabetes.com/battery-cap-guide.
Medtronic MiniMed 630G and 670G Retainer Ring Issues
This recall affects MiniMed™ 600 series insulin pumps with a clear retainer ring. Medtronic first communicated about this recall in November 2019 with instructions to examine your pump for potential retainer ring damage and instructions to contact us if the retainer ring appeared to be loose, damaged, or missing.
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Medtronic is updating this recall to replace any MiniMed™ 600 series insulin pump that has a clear retainer ring with a MiniMed™ 600 series insulin pump that has the updated black retainer ring design. Insulin pumps with the updated black retainer ring design are not impacted by this recall. There is no charge for the replacement, and it will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.
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The MiniMed™ 600 series insulin pump is designed with a pump retainer ring to lock the reservoir in the insulin pump. There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface.
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If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia. For example, if the pump retainer ring is broken or becomes detached from the pump, and the user inserts the reservoir back into the pump while the infusion set is still connected to the body, it could result in a rapid infusion of insulin, which could cause hypoglycemia. The under delivery of insulin could occur if the reservoir is not properly locked in place by the retainer ring, creating a space between the pump and the reservoir, and prevent the pump from pushing the expected insulin into the body, which could cause hyperglycemia.
This issue may affect users of the MiniMed™ 630G and 670G insulin pumps. The pump model number can be found directly on the bottom or on the back of the device. ​
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MiniMed™ 630G insulin pump: MMT-1714, MMT-1715, MMT-1754, MMT-1755
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MiniMed™ 670G insulin pump: MMT-1580, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782
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Please visit www.medtronicdiabetes.com/PumpRing and complete the form online or call us at 1-877-585-0166 to indicate your decision to receive a replacement pump at no charge. Replacement pumps will become available in the coming months, and you will be notified when your pump is ready to ship. Replacement pumps will continue to be immediately available if you experience an issue with the retainer ring on your current pump.
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Visit www.medtronicdiabetes.com/PumpRing for more information.