Medtronic recalls bariatric kits with possible missing sled component causing staple deployment failure, leading to bleeding or leakage. Affected units include specific lot numbers and item codes.
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Medtronic is recalling bariatric kits that may have a missing sled component, which can cause staple deployment failure during tissue division. This could lead to bleeding or leakage of luminal contents if the kit is used improperly.
The sled component is critical for staple deployment. If missing, the kit may fail to form a staple line when dividing tissue, potentially causing bleeding or leakage of internal contents.
Patients using the Medtronic Bariatric Kit X1 for weight loss surgery are most at risk. The recall affects specific lot numbers and item codes sold in the United States.
Check for item code KITBAR021- BARIATRIC KIT X0 or SGGLOGX1 ZESTAW DO BARIATRII on the product packaging. Affected units include specific lot numbers listed in the recall notice.
Look for item code KITBAR021- BARIATRIC KIT X0 or SGGLOGX1 ZESTAW DO BARIATRII on the packaging.
Reach out to Medtronic for further instructions on the recall process.
The sled component may be missing, which can cause staple deployment failure during tissue division, leading to bleeding or leakage of luminal contents.
Affected lot numbers include 0214049704, 0214529057, 0215176564, 0215065486, 0215017846, 0215191012, and 0215218687.
The recall does not require immediate stop use; however, affected units should be checked for the missing sled component.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1843-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1843-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
