Medical device manufacturer Insulet is recalling some of its insulin pumps after 18 serious patient events.
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Medical device manufacturer Insulet is recalling some of its insulin pumps after 18 serious patient events, in a move expected to cost the Acton-based firm up to $40 million.
In the 18 patient events, Insulet’s Omnipod 5 Pods, which are tubeless insulin pumps for people with diabetes, developed small tears in the internal tubing. This caused insulin to partially leak into the device, instead of being fully delivered into the patients’ bodies, according to a Thursday press release.
Some of the patients had to be hospitalized and/or developed diabetic ketoacidosis, a life-threatening condition caused by low blood sugar.
As a result, Insulet voluntarily initiated a medical device correction for some of its Omnipods. Under U.S. Food and Drug Administration regulations, this type of recall corrects aspects of device production, including repairs, modifications, relabeling and destruction, according to the FDA.
Approximately 1.5% of the Insulet’s global annual Omnipod 5 production was included in the correction, which included updates to its manufacturing processes and quality controls.
While Insulet said it is too early to determine the cost of the correction, the manufacturer estimates it could cost up to $40 million to implement, according to a Thursday filing with the U.S. Securities and Exchange Commission.
“Patient safety and product quality remain Insulet’s highest priorities,” Insulet said in the release.
Insulet’s correction comes after the manufacturer implemented a similar voluntary medical device correction on its Omnipod DASH Personal Diabetes Manager in October 2022.
Mica Kanner-Mascolo is a staff writer at Worcester Business Journal, who primarily covers the healthcare, manufacturing, and higher education industries.
