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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a mechanical failure could lead to bleeding or leakage, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic is recalling specific lots of Endo GIA Universal and Endo GIA Universal XL staplers. The recall involves 171,271 units distributed worldwide and in the United States. The affected products are identified by specific lot numbers, including 0214050554 and a group of four additional lots.
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 stapler 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 affected lot numbers. If the recalled devices are found, they should be removed from use and returned to Medtronic according to the company's instructions.
The recalled product
- Product
- (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1 APPENDIX KIT ZAMS) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered
- 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)
- (1) Lot Number: 0214050554 (2) Lot Numbers: 0214907029
- 0214991119
- 0215130754
- 0215158268
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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