Medtronic Recalls Bariatric Staplers Due to Missing Sled Component
Medtronic is recalling specific bariatric stapler 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 could 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 169,775 units of specific bariatric stapler kits, including the Bariatric Tristaple, Alternative Appendix Kit, and Kit App Stapler. The affected products are distributed worldwide and in the US nationwide.
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 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 patients should check their inventory and records for the specific lot numbers listed in the recall notice. If the affected products are in use, they should contact Medtronic for instructions on replacement or return.
The recalled product
- Product
- (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03533 KIT APP STAPLER (Item Number: PST03403) Product Usage: The Endo GIA universal and End
- 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 (2)
- Lot Numbers: (1) 0214109631
- 0214909770 (2) 0214975597 (3) 0214860061
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