Medtronic Provides Update on Recall of Thousands of Defective Insulin Pumps and Remote Controls
Insulin pumps included in the Medtronic MiniMed 600 series and remote controls in the 500 series have been recalled due to a device malfunction that can result in incorrect insulin dosing and cybersecurity risks in the remote controls. If you have one of these devices, stop using immediately and fill out a request form for a free replacement.
Medtronic recently announced an update about its recent device recall, which includes all pumps in the MiniMed 600 series. This includes the 630G and 670G insulin pumps, which have been on the market globally for the last five years. According to the FDA, this is a serious and urgent recall due to the severity of improper insulin dosing, which can result in serious injury or death. This update from Medtronic is not due to any new issues with the MiniMed 600 series pumps since the initial recall announcement in 2019, but is a reminder for users who have yet to apply for and receive a replacement pump.
Medtronic and the FDA have both urged users to immediately replace any pump that has a clear retainer ring with an updated pump that has a black retainer ring. The retainer ring helps lock the insulin cartridge in place, and when damaged, can deliver an improper insulin dose, placing the user at a higher risk for hypo- or hyperglycemia. While the recall targets all pumps with a clear retainer ring, only pumps with a damaged clear retainer ring put users at risk. If the clear retainer ring is not damaged, users can continue to use their pump safely until a replacement arrives. There is no charge for the replacement pump, regardless of the pump’s warranty status.
This updated recall expands on an earlier recall order issued by Medtronic, which targets the remote controls (the MMT-500 and MMT-503) for the MiniMed 508 or MiniMed Paradigm insulin pumps. In 2018, a cybersecurity threat was identified where someone in close proximity to an insulin pump user could mimic the wireless remote signal and deliver an additional bolus to the user. According to Medtronic, there have not yet been any reports of injuries or death related to this issue, however it advised users of this model, which is no longer manufactured, to immediately disconnect the remote from the pump and return it.
For users of insulin pumps in the MiniMed 600 series, the company issued recommendations:
First, determine if the retainer ring on your pump is clear, and whether it is damaged or missing. A diagram on how to locate the retainer ring can be found here.
If the retainer ring is damaged or missing, immediately stop using your pump and switch to a back-up plan for insulin delivery, based on your healthcare provider’s recommendations.
If the retainer ring is clear but still functions properly, you may continue to use your pump until you receive a replacement. Regardless of whether or not the retainer ring is damaged, all users are eligible to receive a replacement.
In order to receive a replacement, fill out a replacement request form or call Medtronic’s 24-hour technical support line at 1-877-585-0166.
For more information about this recall and to request technical support or a replacement pump, visit this page.