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, leading to 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) due to device failure, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Universal and Endo GIA Universal XL staplers (Item Code KIT1095V) due to a potential manufacturing defect. The affected devices may be missing a sled component, which 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 the leakage of luminal contents during surgical procedures. The recall covers units distributed worldwide and in the US nationwide.
Healthcare providers and facilities should check their inventory for the affected lot (Lot 0214062622) and stop using these devices. Patients who have had surgery with these devices should contact their healthcare provider if they experience complications such as bleeding or leakage.
The recalled product
- Product
- BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) 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 i
- 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 (1)
- Lot 0214062622
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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