Medtronic Recalls Bypass Kits Due to Missing Stapler Component
Medtronic is recalling 171,271 Endo GIA Bypass Kits 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 medical device defect that can lead to significant injury, specifically bleeding or leakage of luminal contents, which aligns with the 'Severe' criteria for significant injury reports or high-risk device failures.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Bypass Kit (KITDE0108) due to a potential manufacturing defect. The recall covers products distributed worldwide and in the US nationwide. The specific lot number is 0214894171.
The recall was initiated because the device may be missing a sled component, which is responsible for deploying staples. If this component is missing, the stapler may fail to form a staple line when dividing tissue. This failure could lead to bleeding or the leakage of luminal contents during surgical procedures.
Healthcare providers and facilities should stop using the affected kits and contact Medtronic for further instructions. Patients who have had surgery using these devices should contact their healthcare provider if they experience complications such as bleeding or leakage.
The recalled product
- Product
- BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) 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
- 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: 0214894171
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
Same manufacturer · COVIDIEN MEDTRONIC
See all →- SevereMedtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Stapler Recall Due to Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
FDA (Devices) · 2018-07-25
Same hazard · bleeding
See all →- HighHollister Recalls Onli Hydrophilic Urethral Catheters Due to Manufacturing Defect
FDA (Devices) · 2026-09-02
- SevereCannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
FDA (Devices) · 2026-05-20
- SevereArrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereNextStep Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereArrow Edge hemodialysis kits contain a sheath introducer that may not split
FDA (Devices) · 2026-05-20