Tandem Diabetes Care has issued a Voluntary Medical Device Recall for specific lots of insulin cartridges used with the t:slim® Insulin Pump, noting that the affected cartridges may be at risk for leaking. Affected lot numbers are listed below.
A cartridge leak could potentially result in the delivery of too much or too little insulin, which could lead to unexpected high or low blood glucose levels. Too much insulin can result in severe low blood sugar (hypoglycemia), and too little insulin can lead to severe high blood sugar (hyperglycemia), both of which can lead to serious injury or death.
We have identified the cause of the potential cartridge leak and have modified our cartridge manufacturing testing process to prevent this issue from occurring in the future.
We sincerely apologize for the inconvenience. Your safety is our top priority, and we are committed to quickly addressing issues when they arise. Our goal is to always provide you with quality products and superior customer service.
Copy of Initial Recall Letter to Customers - Jan. 10, 2014 (pdf)
Copy of Recall Expansion Letter to Customers - Jan 20, 2014 (pdf)
You can find the cartridge lot number on the rear panel of the cartridge box and on the packaging of each individual cartridge.
The affected cartridges cannot be identified by inspecting the cartridges themselves.
What is the issue?Specific lots of cartridges for the t:slim Insulin Pump may be at an increased risk for leaking. A cartridge leak could potentially result in the delivery of too much or too little insulin, which could lead to unexpected high or low blood glucose levels. Too much insulin can result in severe low blood sugar (hypoglycemia), and too little insulin can lead to extremely high blood sugar (hyperglycemia), both of which can lead to serious injury or death.
Has there been any serious injury or death related to this potential risk?The recall was initiated based on information identified during Tandem’s own internal testing, not from any complaints or adverse events reported by customers. We are asking anyone with affected product to let us know if they have experienced any adverse events using the Return Response form included with the letter mailed to them, or to call Technical Support at (877) 801-6901.
How do we know there aren’t more lots that are going to be recalled?
The safety of our customers is our top priority. For that reason, even after our January 10, 2014 announcement, we continued to study the specific issue. Based on this work we recognized that additional cartridges could be at risk for leaking and so we expanded the scope of this recall. We have now evaluated all manufacturing lots that may have been shipped to customers and are confident that all affected cartridge lots have been identified.
Is there anything wrong with my t:slim Insulin Pump?No. This recall relates only to cartridges, and only cartridges from the specific lots referenced in this notification.
I already used one of the affected cartridges. Do I need to worry about my pump?No. The affected cartridge would not have caused any damage your t:slim Pump.
What solution is Tandem offering to affected customers?Tandem is replacing all affected, unused cartridges that customers have on hand at no cost, and as quickly as possible. However, it is important that you follow the instructions in this notice as the affected cartridges cannot be identified by inspection.
Was the recall issued by Tandem or the FDA?Tandem voluntarily issued this recall notification and has already notified the US Food and Drug Administration (FDA) of our decision to voluntarily recall these cartridges.
Can I finish using my current cartridge? I just started using it and it is full of insulin.You should stop using a cartridge from an affected lot right away, even if you need to discard some insulin. We recognize there will be some insulin waste and deeply apologize for this situation. Please know we are making this recommendation for your safety.
How will Tandem address this in the future to avoid similar problems?We have identified the cause of the potential cartridge leak and have already modified our cartridge manufacturing process to prevent this issue from occurring in the future.
My blood sugar has been running higher/lower than normal. Do you think this is the cause?There are various reasons for why blood sugar can run higher or lower than normal. Please contact our Customer Support team so we can help determine if the issue is product related. You should also contact your healthcare provider.
I have cartridges affected by the recall. What should I do?
Please call Tandem Technical Support to receive replacement cartridges at no charge. We will also provide you with instructions and pre-paid packaging to return your affected cartridges to us. Tandem Technical Support is available 24 hours a day, 7 days a week at 1-877-801-6901.
I didn’t purchase my cartridges directly from Tandem. I got them from a distributor. Who do I contact about replacement cartridges?
Please call Tandem Technical Support and we can help determine the best way to get your replacement cartridges delivered. Tandem Technical Support is available 24 hours a day, 7 days a week at 1-877-801-6901.
Is this going to delay my current cartridge order?
We are actively shipping replacement cartridges, but you may receive your order in multiple shipments. If you are running low on cartridge supplies, please contact Tandem Customer Support at 1-877-801-6901 so that we can help make sure you don’t have any interruption of therapy.
Has Tandem contacted my healthcare professional?Tandem is notifying healthcare professionals that prescribe and support the t:slim Pump. If your HCP has any questions, please encourage them to contact Tandem Technical Support at 1-877-801-6901.