Medtronic Endo GIA Universal Stapler Kits Recalled for Missing Sled Component
Medtronic is recalling Endo GIA Universal stapler kits 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 high-risk medical device defect that could lead to serious injury (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 where injury has not yet been reported.
Plain-English summary
Medtronic is recalling specific lots of Endo GIA Universal and Endo GIA Universal XL stapler kits (Box Kit 00714 Kit Sleeve). The recall involves 171,271 units distributed worldwide and across the United States. The affected lots are 0214915642, 0214983138, 0215159225, and 0215234652.
The recall is due to a potential defect where the device may be missing a sled component. This component is responsible for staple deployment. If the sled is missing, the device may fail to form a staple line when tissue is divided during surgery. This failure could lead to bleeding or leakage of luminal contents.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices. Patients who have had surgery using these specific devices should contact their healthcare provider if they experience complications such as bleeding or leakage.
The recalled product
- Product
- BOX KIT00714 KIT SLEEVE 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 by the s
- 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 0214915642
- 0214983138
- 0215159225
- 0215234652
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.
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