UPDATED Sept. 11, 2015 with Class I status news.
Insulet (NSDQ:PODD) last month recalled more than 408,000 of its OmniPod diabetes devices after receiving reports of problems affecting their ability to deliver insulin.
The FDA said yesterday that the July 8 recall is based on the possibility that the affected OmniPods’ failure rate may exceed Insulet’s standards. The problem is either with the cannula OmniPod uses to deliver insulin, which can either retract or fail to deploy, or an alarm indicating that the device stopped delivering insulin and needs to be replaced, according to the safety watchdog.
The recall does not affect the OmniPod’s wireless controller, the FDA said. The agency said it received 90 medical device reports on the affected OmniPod lots, including 13 that required medical treatment.
Billerica, Mass.-based Insulet distributed 40,846 boxes, with 10 OmniPods each, from December 2013 to March 2015 in the U.S., Austria, Germany, Italy, Netherlands, Norway, Sweden, Switzerland and the U.K. The company is arranging for the return and replacement of the affected devices, the FDA said.
The agency gave the recall Class I status Sept. 10, denoting a problem that could result in serious injury or death.
Here’s a look at the catalog and lot numbers involved in the recall:
Distribution | Catalog Number | Description | Lot Number |
---|---|---|---|
United States | POD-ZXP420 | OmniPod® Insulin Management System | L40806 L40811 L40895 L40976 L41014 L41025 L41067 L41162 L41171 L41197 L41198 L41250 |
International | 14810 | OmniPod® Insulin Management System | L40771 L40892 L40901 L40905 L40997 L41199 L41208 |