Medtronic Recalls Bariatric Surgical Kits Due to Missing Staple Sled Component
Medtronic is recalling 169,775 bariatric surgical kits worldwide because a missing sled component may prevent staple formation, risking 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 structural defect in a surgical device that can lead to significant injury, specifically bleeding or leakage of luminal contents.
Plain-English summary
Medtronic is recalling 169,775 units of bariatric surgical kits, including the Endo GIA universal and Endo GIA universal XL staplers, distributed worldwide and in the US. The recall involves specific lot numbers for items such as the Bariatric Kit and Resection Sleeve Kit.
The recall was initiated because the device 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 surgery.
Healthcare providers and facilities should stop using the affected lots immediately and contact Medtronic for instructions on how to return or replace the devices.
The recalled product
- Product
- (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Code: SGGLOGX1 ZESTAW DO BARIATRII (4)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Coder:SGGLOGX1 ZESTAW DO BARI
- 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 (3)
- Lot Numbers: (1) 0214049704
- 0214529057
- 0215176564 (2) 0215065486 (3) 0215017846 (4) 0215191012 (5) 0215218687
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
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- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
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- 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
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