The FDA has issued early alerts for two high-risk medical device issues involving products from Intuitive Surgical and Insulet.
Intuitive Surgical sent a notice March 11 advising customers to remove all 8 mm SureForm 30 gray reloads for curved-tip staplers from use or sale, according to the FDA alert. The staplers have been linked to incomplete staple lines on blood vessels, causing bleeding that may require conversion to open surgery. As of Feb. 23, one death and four serious injuries have been reported. Affected part numbers include 48230M-05 and 48230M-06; the UDI is 00886874121931.
On March 12, Insulet notified customers of potential tubing tears in certain Omnipod 5 Pods that could cause insulin to leak inside the device rather than be delivered as intended. The FDA said this could result in dangerously high blood glucose levels and, in severe cases, diabetic ketoacidosis. Insulet reported 18 serious injuries related to the issue. The affected UDI is 10385083000527.
Both manufacturers advised customers to stop using affected products immediately. The FDA said it continues to evaluate both cases and will update its alerts as new information becomes available.
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