(1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium s
Check against the official notice below — it lists the full affected range.
Covidien Medtronic is recalling two lobectomy kits: the APEN LOBECTOMY KIT (Item Number KIT4184) and the VATS LOBECTOMY KIT (Item Number VATSLOB11). The devices may be missing a sled component that is responsible for deploying staples. If the sled component is missing, the device may fail to form a proper staple line when tissue is divided, potentially resulting in bleeding or leakage of luminal contents. A total of 171,271 units have been distributed worldwide and throughout the United States across specific lot numbers.
The recall affects lot numbers 0214962218 for the APEN kit and lot numbers 02148663335, 0214993030, and 0215178525 for the VATS kit. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide and US Nationwide Quantity: 171,271 units in total Lot/code info: (1)Lot Number: 0214962218 (2) Lot Numbers: 02148663335, 0214993030, 0215178525
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.