Medtronic Endo GIA Universal Bypass Kits Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA Universal Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 structural defect that can lead to significant injury (bleeding or leakage of luminal contents), meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling 171,271 units of the KIT-DE-0080 Bypass Kit Lohne X1, which includes Endo GIA Universal and Endo GIA Universal XL staplers. The recall covers specific lots (0214049646, 0214370002, 0214470664, 0215208426) distributed worldwide and in the US.
The recall is due to a potential manufacturing 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, which 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 kits. Patients who have had surgery using these specific kits should contact their healthcare provider if they experience complications such as bleeding or leakage.
The recalled product
- Product
- KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) 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…
- 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 0214049646
- 0214370002
- 0214470664
- 0215208426
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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