Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (bleeding or leakage of luminal contents) due to a structural defect in the device.
Plain-English summary
Medtronic is recalling specific lots of the Endo GIA Universal and Endo GIA Universal XL staplers, identified by the product name BOX KIT1171C KIT LAP CYSTECTOMY. The recall involves 171,271 units distributed worldwide and across the United States. The affected lots are 0214090852, 0214522213, 0215009132, and 0215153445.
The recall was initiated because the device may be missing a sled component. This component is responsible for deploying the staples. If the sled is missing, the device may fail to form a staple line when tissue is divided. This failure can lead to bleeding or the leakage of luminal contents during surgical procedures.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed above. If the affected units are found, they should be removed from use and returned to Medtronic or the distributor as directed. Patients who have had procedures using these devices should contact their healthcare provider if they experience complications such as bleeding or leakage.
The recalled product
- Product
- BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 171,271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots 0214090852
- 0214522213
- 0215009132
- 0215153445
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by COVIDIEN MEDTRONIC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 40 products in this recall →Related recalls
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