Medtronic recalls two types of Endo GIA lobectomy kits that may have a missing sled component, risking bleeding during tissue division. Affected kits include KIT4184 and VATSLOB11 models with specific lot 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 two types of surgical kits for lobectomy procedures because they might be missing a critical sled component. This could cause bleeding or leakage of tissue during surgery if the staples fail to form a proper line.
The sled component is essential for deploying staples correctly during tissue division. If missing, the staples may not form a secure line, leading to bleeding or leakage of internal tissues.
Surgical teams using the Endo GIA lobectomy kits for procedures like lung or liver surgery are most at risk. Patients undergoing these procedures with the affected kits could experience bleeding or leakage.
Check for the item numbers KIT4184 APEN LOBECTOMY KIT XO or VATSLOB11 ZESTAW DO VATS LOBECTOMII. The affected kits have specific lot numbers: 0214962218, 02148663335, 0214993030, and 0215178525.
Verify the lot number on the kit packaging to see if it matches the affected numbers: 0214962218, 02148663335, 0214993030, or 0215178525.
Reach out to Medtronic directly for confirmation of the kit's status and instructions on next steps.
The kits may be missing a sled component that is needed for staple deployment. This could cause bleeding or leakage of tissue during surgery.
The Endo GIA lobectomy kits with item numbers KIT4184 APEN LOBECTOMY KIT XO and VATSLOB11 ZESTAW DO VATS LOBECTOMII, and specific lot numbers: 0214962218, 02148663335, 0214993030, 0215178525.
No, but you should check the lot numbers and contact Medtronic for guidance since the hazard requires caution during use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1838-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1838-2018 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.
