Medtronic Endo GIA Stapler Recall Due to Missing Sled Component
Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to 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 is classified as FDA Class II and involves a risk of harm (bleeding or leakage) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic is recalling 169,775 units of the SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 (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 can lead to bleeding or leakage of luminal contents during surgical procedures. The affected units were distributed worldwide and in the US nationwide.
The recall is classified as Class II by the FDA. Healthcare providers and patients should check their inventory and usage records for the specific lot number 0215244887. If the device is found to be missing the sled component, it should not be used.
The recalled product
- Product
- SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 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 deter
- 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 (1)
- Lot: 0215244887
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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