COVIDIEN Medtronic Recalls Endo GIA Staplers for Missing Sled Component
COVIDIEN Medtronic is recalling approximately 171,271 Endo GIA universal staplers because a missing sled component may prevent proper staple deployment. This defect can lead to bleeding or leakage of luminal contents during surgery.
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 agency classification is FDA Class II, and the hazard involves potential serious injury (bleeding or leakage) due to device malfunction. According to the rubric, FDA Class II with significant injury reports or risk of serious harm warrants a Severe score.
Plain-English summary
COVIDIEN Medtronic has initiated a Class II recall affecting approximately 171,271 units of the Endo GIA universal and Endo GIA universal XL staplers. The affected products include item numbers HEMIGX1 ZESTAW DO HEMICOLECTOMII (lot numbers 0214909888, 0214916144) and LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (lot numbers 0215015272, 0215298205). These devices are distributed worldwide and within the United States.
The recall is necessary because the device may be missing a sled component. The sled is responsible for staple deployment. If this component is absent, the stapler may fail to form a proper staple line when tissue is divided. This failure can result in bleeding or leakage of luminal contents during surgical procedures.
The recalled product
- Product
- (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place t
- 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 (3)
- Lot Numbers: (1) 0214909888
- 0214916144 (2) 0215015272
- 0215298205
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 →Related recalls
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