In 2019, Medtronic initiated a recall of MiniMed 600 series insulin pumps with a clear retainer ring design because of reports that the pump’s insulin reservoir could not be locked into place if the ring was damaged. Customers were notified that pumps with clear retainer rings would be replaced if the ring was damaged or missing with an equivalent pump that has an updated black retainer ring designed to better withstand damage sustained by an accidental drop or bump on a hard surface. Medtronic is announcing an update to that recall and will proactively replace all clear retainer ring pumps, whether the ring is damaged or not, with an equivalent pump with the black retainer ring design. Medtronic will replace pumps at no charge over the coming months regardless of the warranty status of the pump. This update is not in response to any new issues since the start of the recall in 2019. Insulin pumps with an updated black retainer ring design are not impacted by this recall and do not need to be replaced.

OVERVIEW OF RETAINER RING ISSUE
The MiniMed™ 600 series insulin pump is designed with a retainer ring that locks the insulin reservoir in the pump. Since November of 2019, Medtronic has been replacing pumps with damage to the clear retainer ring because of reports that the pump’s insulin reservoir could not be locked into place if the clear retainer ring was damaged. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can break, for example, as a result of dropping or bumping the pump on a hard surface.

An improperly locked reservoir could lead to over- or under-delivery of insulin and potentially result in hypoglycemia or hyperglycemia. Severe hypoglycemia and hyperglycemia can be life-threatening or may result in death.

SAFETY DATA REVIEW
Serious injuries including deaths have been reported with the use of the MiniMed™ 600 series insulin pumps with clear retainer rings. The review of safety data, which included an assessment by a panel of independent medical experts, has not confirmed that those adverse events were directly related to the damaged clear retainer rings that are the basis for this recall. In the spirit of our Medtronic Mission, we are proactively accelerating our replacement plan so we can strive for the greatest possible reliability and quality in our insulin pumps and help patients optimally manage their diabetes.

“Insulin pumps are sophisticated medical technologies that work to normalize blood glucose levels as much as possible in individuals with diabetes who don’t have the ability to produce insulin naturally. As with all therapies, there are risks that should be considered when a patient and their healthcare provider decide to use a pump for insulin delivery rather than multiple daily injections. The totality of evidence from both controlled, large scale clinical trials and real-world studies strongly support the safety and benefits of insulin pump therapies^[1],” Robert Vigersky, M.D., chief medical officer of the Diabetes business at Medtronic.

NOTIFICATION PLAN
Medtronic is notifying all patients that have a clear retainer ring pump with instructions on 1) how to check their pump for this issue and 2) the process for requesting a replacement. If the patient observes that the insulin reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, patients should immediately stop using their insulin pump and switch to their back-up therapy plan which should always be in place as guided by their healthcare provider. Customers experiencing these issues with the clear retainer ring on their current insulin pump will receive a priority replacement and Medtronic will ship remaining replacements to those not experiencing an immediate issue as they become available over the coming months.

“Patient safety is always our top priority and we strongly believe this is the right thing to do based on our ongoing assessment,” said Sean Salmon, executive vice president and president of the Diabetes business at Medtronic. “We know recalls like this create disruption and concern, so our focus is to offer our full support and ensure patients have all the information they need to make the best decisions related to their diabetes management. We are working diligently to quickly reach all patients who still have clear retainer ring pumps via email, postal mail, text messaging as appropriate, and the Medtronic Diabetes website to ensure they are informed about this important update.”

PROCESS FOR REQUESTING A REPLACEMENT

Patients whose pumps are affected by this recall should follow the instructions in the recall communication from Medtronic, which asks them to complete an online form at www.medtronicdiabetes.com/PumpRing. Patients can also contact the Medtronic 24-Hour Technical Support line at +1-877-585-0166 to start the replacement process.

^[1] https://global.medtronic.com/xg-en/e/response/insulin-pumps.html