The Recall Desk
SevereFDA (Devices)·Z-1823-2018·Announced 2018-05-23

Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component

Medtronic is recalling specific Endo GIA vascular reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (bleeding or leakage of luminal contents) due to a structural defect in the device.

Plain-English summary

Medtronic is recalling 171,271 units of the Endo GIA 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple Technology (Item Code EGIA45CTAV). The recall covers lots N7G0796KX and N7L0818KX, which were distributed worldwide and across the United States.

The recall was initiated because the device may be missing a sled component. This component is responsible for staple deployment. If the sled is missing, the device may fail to form a staple line when tissue is divided, which could lead to bleeding or leakage of luminal contents.

Healthcare providers and facilities should check their inventory for the affected item code and lot numbers. If the product is found, it should be removed from use and returned to Medtronic according to their instructions.

The recalled product

Product
Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) 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
Manufacturer
COVIDIEN MEDTRONIC
Affected units
171,271

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: N7G0796KX & N7L0818KX

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 40 recalled by COVIDIEN MEDTRONIC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 40 products in this recall →