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 risk of significant injury (bleeding or leakage of luminal contents), which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Medtronic is recalling approximately 169,775 units of Endo GIA universal and Endo GIA universal XL staplers. 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 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. The affected lots are 0214874566, 0215001737, and 0215151361.
The affected products were distributed worldwide and nationwide in the United States. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have had procedures using these devices should contact their healthcare provider if they experience complications.
The recalled product
- Product
- BOX VATS1SCDX DO ZABIEGOW VATS 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 b
- 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 (3)
- Lots: 0214874566
- 0215001737
- 0215151361
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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