Agency classClass IIOur severity:Severe FDA (Devices)·Z-2511-2018·Announced 2018-07-25

Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

Medtronic is recalling Endo GIA staplers that may be missing a sled component, which could cause staple line failure, bleeding, or leakage during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 a medical device.

Plain-English summary

Medtronic is recalling the Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology (Item Code EGIA454AVM). The recall involves specific units identified by codes N7L0551KX and N7M0877KX. These devices were distributed nationwide in the United States and internationally to numerous countries, including Albania, Algeria, Austria, Belgium, and the United Kingdom.

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. This failure could lead to bleeding or the leakage of luminal contents during a surgical procedure.

Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic for instructions on how to return or replace the affected units. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns about their surgical outcome.

The recalled product

Product: Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM
Manufacturer: COVIDIEN MEDTRONIC
Category: Medical Device — Surgical Stapler
Hazard: bleeding
leakage
mechanical-failure

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)

N7L0551KX & N7M0877KX

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 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 14 products in this recall →

Same manufacturer · COVIDIEN MEDTRONIC

See all →

Severe
Endo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
FDA (Devices) · 2018-07-25
Severe
Medtronic Tri-Staple 2.0 Curved Tip Intelligent Reload Recall for Missing Sled
FDA (Devices) · 2018-07-25
Severe
Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
Severe
Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
Severe
Medtronic Endo GIA Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25

Same hazard · bleeding