Endo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
COVIDIEN MEDTRONIC is recalling Endo GIA 60 mm Articulating Vascular/Medium Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.
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 source text describes a defect that may lead to bleeding or leakage of luminal contents, which constitutes a significant injury risk. Per the rubric, FDA Class II recalls with significant injury reports or risks are classified as Severe (4).
Plain-English summary
COVIDIEN MEDTRONIC is recalling Endo GIA 60 mm Articulating Vascular/Medium Loading Units with Tri-Staple Technology (Item Code EGIA60AVM). The recall is due to a potential defect where the device may be missing a sled component. This component is responsible for staple deployment.
If the sled component is missing, the device may fail to form a staple line when tissue is divided during a procedure. This failure could lead to bleeding or the leakage of luminal contents. The agency has classified this as a Class II recall.
The affected products were distributed nationwide in the U.S. and internationally to numerous countries, including Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, and the United Kingdom. The specific lot codes affected are N7M0045KX, N7M0398KX, N8A0523KX, N8B0088KX, N7M0070KX, N8A0255KX, and N8B0080KX. Healthcare providers should check their inventory for these specific item codes and stop using any affected units.
The recalled product
- Product
- Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM
- Manufacturer
- COVIDIEN MEDTRONIC
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 (6)
- N7M0045KX
- N7M0398KX
- N8A0523KX
- N8B0088KX
- N7M0070KX
- N8A0255KX & N8B0080KX
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 →Related recalls
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See all →- SevereMedtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
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- SevereMedtronic Endo GIA Stapler Recall Due to Missing Sled Component
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- SevereMedtronic Endo GIA Reloads Recalled for Missing Sled Component
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Similar recalls
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