Medtronic Endo GIA Universal Stapler Sleeves Recalled for Missing Sled Component
Medtronic is recalling Endo GIA Universal stapler sleeves and bypass units because a missing sled component may prevent staple formation, risking 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 medical device defect that could lead to bleeding or leakage of luminal contents, which are significant injury risks, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic is recalling 169,775 units of Endo GIA Universal and Endo GIA Universal XL stapler sleeves and bypass units. The affected products include Item Numbers PST04089 and PST04090, distributed worldwide and in the US.
The recall is due to a potential missing sled component, which is responsible for staple deployment. If the component is missing, the device may fail to form a staple line when tissue is divided. This failure could lead to bleeding or leakage of luminal contents during surgical procedures.
Healthcare providers should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected units. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns about their surgical outcome.
The recalled product
- Product
- (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, tr
- 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 (9)
- Lot Numbers: (1) 0215237526
- 0214991351
- 0214991350
- 0215157998
- 0215157997 (2) 0215237527
- 0215282382
- 0214991349
- 0214991348
- 0214991347
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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