Medtronic, Inc. is recalling certain Endo GIA surgical staplers because of potentially missing components.
According to MassDevice.com, the surgical stapler recall involves select lots of Endo GIA single-use loading units, Tri-Staple 2.0 intelligent reloads, and cartridges with the following product codes:
The recalled devices were distributed between April 2014 and April 2019.
Medtronic is warning that the affected staplers may be missing one of two pin components intended to maintain alignment of the device jaws. This could result in incomplete staple formation, leading to to bleeding, anastomotic leak, peritonitis or pneumothorax. Such an occurrence could ultimately result in an infection or sepsis.
So far, Medtronic has not received any reports of injuries or complications related to the recalled staplers.
Unfortunately, it appears Endo GIA devices affected by a May 2018 surgical stapler recall did cause at least four patient injuries. Those products were apparently missing sled component designed for staple deployment.
“Use of a product with this issue may result in a failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents,” the company stated at the time.
Last month, the U.S. Food & Drug Administration (FDA) granted Class I designation to a surgical stapler recall involving more than 92,000 unites of Ethicon, Inc.’s:
That recall came after the staplers reportedly misfired during two resections of the upper rectum. Surgeons were forced to perform an additional resection — of the middle rectum in one patient and the lower rectum in another — during both procedures.
A Class I designation is the FDA’s most serious recall category and indicates that the affected devices pose a significant risk of patient injury or death.
Internal surgical staplers are currently classified as low risk medical devices. However, the FDA is considering reclassifying the products as moderate risk devices, which would subject such staplers to a higher degree of regulatory oversight.
According to the agency, internal surgical staples have been linked to thousands of patient injuries and malfunctions, including more than 300 deaths.
Late last month, the FDA’s General and Plastic Surgery Devices Panel unanimously voted in favor of the proposal.