Medtronic Endo GIA 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 structural defect that can lead to significant injury, specifically bleeding or leakage of luminal contents.
Plain-English summary
Medtronic is recalling specific units of the Endo GIA universal and Endo GIA universal XL staplers, identified by the product name BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS. The recall involves 169,775 units distributed worldwide and across the United States. The affected lots are 0215124172 and 0215253056.
The recall is being issued 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 could 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 authorized distributor according to the recall instructions.
The recalled product
- Product
- BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS 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 de
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 169,775
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 (2)
- Lot: 0215124172
- 0215253056
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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