Dive Brief:
- FDA on Tuesday posted two updates to past recalls involving several models of Medtronic's MiniMed insulin pumps.
- Medtronic is offering to replace all MiniMed 600 series insulin pumps that have a clear retainer ring, in connection with the company's November 2019 recall involving nearly 500,000 of the devices, FDA said. The retainer ring flaw has been linked to 26,421 complaints, 2,175 injuries and one death, the agency said in its February 2020 recall notice.
- In a separate update, FDA said Medtronic expanded an August 2018 recall of remote controllers used with the MiniMed 508 and Paradigm family of insulin pumps due to cybersecurity risks. FDA said it was unaware of any reports of harm to patients related to the cybersecurity problem.
Dive Insight:
Since the 2019 recall began, Medtronic has been replacing MiniMed 630G and 670G pumps with retainer rings that are loose, missing or damaged, and the update does not introduce any new issues, said company spokesperson Pamela Reese.
"We are accelerating our replacement efforts based on our analysis of data in order to enhance the reliability and quality of the pumps over the long term," Reese said. Pumps will be replaced at no charge even if the retainer ring is not damaged and regardless of the warranty status of the pump.
Retainer rings are meant to help lock the insulin cartridge in place but, if broken or missing, could lead to the device delivering too much or too little insulin to the patient. Medtronic will replace the affected pumps with an equivalent pump that has an updated black retainer ring designed to better withstand damage that could result from an accidental drop or bump on a hard surface, Reese said.
While serious injuries and deaths have been reported with use of the MiniMed 600 series pumps, the adverse events may not have been directly related to the damaged clear retainer rings, FDA said in its update. Medtronic no longer manufactures or distributes pumps with clear retainer rings.
In a second recall, FDA said patients should stop using any MiniMed model MMT-500 and MMT-503 remote controller with a 508 or Paradigm insulin pump and return the remote controller. The devices, designed to communicate wirelessly with the pump to deliver a specific amount of insulin to the patient, are older models that were distributed between August 1999 and July 2018 and are no longer being manufactured, FDA said.
Medtronic is recalling 31,310 of the devices because an unauthorized person could record the wireless communication between the remote and insulin pump and, with specialized equipment, instruct the device to over-deliver insulin or stop delivery, FDA said. Patients who have not programmed a remote controller ID into the pump or selected the related bolus option are not affected.
The recalls have hit Medtronic at a time when competitors Insulet and Tandem are ramping up in the insulin pump market. Medtronic was the market share leader in insulin pumps, having benefited from Johnson & Johnson's exit from the sector in 2017. It has also faced strong competition in the market for continuous glucose monitoring devices, where Dexcom and Abbott are growing sales.
In Medtronic's first fiscal year 2022 quarter ended July 30, the company's diabetes unit sales of $572 million missed expectations by $13 million, with a miss of $47 million in the U.S., according to J.P. Morgan.
Medtronic CEO Geoff Martha, on the company's earnings call, acknowledged the diabetes share losses, which the company hopes to turn around with the introduction of its MiniMed 780G pump. The system has launched in international markets and is under FDA review.
A new seven-day Guardian 4 sensor is also being reviewed by FDA, and the company plans to submit its next-generation Synergy CGM sensor to FDA in the third quarter, Martha said. The Synergy sensor is disposable, easier to apply and half the size of Medtronic's current sensor, he said.
