COVIDIEN MEDTRONIC: Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) Product Usage: The Endo GIA universal and Endo GIA universal XL stapler

Is my product affected?

Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-sta

• UPC 10884521186095
• UPC 20884521186092

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling Endo GIA 30mm Gray Curved Tip Articulating Vascular Reload cartridges (Item Code EGIA30AV) used with Endo GIA universal and Endo GIA universal XL staplers. The devices may be missing a sled component that is responsible for deploying staples. If the sled is missing, the stapler may fail to form a proper staple line when tissue is divided, which could result in bleeding or leakage of internal contents. The recall affects 171,271 units distributed worldwide and throughout the US, specifically Lot N7G0757KX.

The recall notice does not specify a remedy or recommended action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: Lot: N7G0757KX GTIN # 1 (Inner Carton) - 10884521186095 GTIN # 2 (Outer Carton)- 20884521186092

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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