Medtronic Endo GIA Stapler Kits Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA stapler kits worldwide because a missing sled component may prevent staple formation, leading to 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 in a surgical device that can lead to significant injury, specifically bleeding or leakage of luminal contents.
Plain-English summary
Medtronic is recalling 171,271 units of Endo GIA universal and Endo GIA universal XL stapler kits, including specific Appendix Lippe Detmold and Appenektomie Kit Nauenx1 models. The recall covers products distributed worldwide and in the US nationwide.
The recall was initiated because the device may be missing a sled component, which is responsible for staple deployment. 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 affected lot numbers listed in the official recall notice. If the missing sled component is identified, the device should not be used. Users should contact Medtronic for further instructions on how to proceed with the recall.
The recalled product
- Product
- (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titan
- 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 (19)
- Lot Numbers (1) 0214014173
- 0214573291
- 0214621781
- 0214909631
- 0215068744
- 0215068743
- 0215108744
- 0215108743
- 0215276369 (2)0214798114
- 0214618312
- 0214795633
- 0215002022
- 0215010930
- 0215010931
- 0215010932
- 0215132611
- 0215132612
- 0215132613
- 0215264173
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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