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 the source text explicitly states that the defect may lead to bleeding or leakage of luminal contents, which constitutes a risk of significant injury.
Plain-English summary
Medtronic is recalling 171,271 units of Endo GIA universal and Endo GIA universal XL staplers (Item Number KIT00486R). The recall covers specific lot numbers: 0213984473, 0213583578, 0213596057, 0214068986, and 0213589227. These devices were distributed worldwide and across the United States.
The recall was initiated because the devices may be missing a sled component, which is responsible for staple deployment. If the sled 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.
Healthcare providers and facilities should check their inventory for the affected lot numbers. If the devices are found, they should be removed from use and returned to Medtronic according to the recall instructions. Patients who have already undergone procedures with these devices should contact their healthcare provider if they experience complications.
The recalled product
- Product
- KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) 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 row
- 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 (5)
- Lot Numbers: 0213984473
- 0213583578
- 0213596057
- 0214068986
- 0213589227
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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