Medtronic recalls bariatric tristaple staples and alternative appendix kits due to risk of failure to form staple lines, potentially causing bleeding or leakage. Affected units include specific lot numbers and item numbers.
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 tristaple staples and alternative appendix kits because a missing sled component can cause staple deployment failure, leading to bleeding or leakage during tissue division. This recall affects specific lot numbers and item numbers of the products.
The sled component is essential for proper staple deployment. If missing, the stapler may fail to form a staple line when dividing tissue, which can cause bleeding or leakage of internal contents.
Bariatric surgery patients using the Endo GIA universal or universal XL staplers with the specified loading units are most at risk. The recall applies to specific lot numbers and item numbers of the products.
Check for item numbers PST01199 (Bariatric Tristaple) and PST03403 (Alternative Appendix Kit) on the product packaging. Affected units have specific lot numbers: 0214109631, 0214909770 for PST01199, 0214975597 for PST03403, and 0214860061 for PST03533.
Identify the item number and lot number on the product packaging to confirm if it is affected.
The sled component may be missing, which can cause failure to form a staple line when dividing tissue, leading to bleeding or leakage of internal contents.
Bariatric Tristaple (item number PST01199) and Alternative Appendix Kit (item number PST03403) with specific lot numbers: 0214109631, 0214909770 for PST01199; 0214975597 for PST03403; and 0214860061 for PST03533.
The recall does not specify a remedy, so check the product details to confirm if it is affected and contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1849-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1849-2018 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.
