Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, risking 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 agency classified this as an FDA Class II recall. The hazard involves a structural defect in a surgical device that can lead to significant injury (bleeding or leakage of luminal contents), meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Auto Suture Universal Articulating Loading Unit (45mm - 2.5mm, Item Code 030454). The recall affects specific lots distributed worldwide and in the US nationwide. The product is a medical device used to place titanium staples and divide tissue during surgical procedures.
The recall was initiated because the device may be missing a sled component, which 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.
Healthcare providers and facilities should stop using the affected loading units and contact Medtronic for instructions on how to return or replace the devices. Patients who have had surgery using these specific units should contact their healthcare provider if they experience complications such as bleeding or leakage.
The recalled product
- Product
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) 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,
- 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 (17)
- Lots: N7K1146KX
- N7L0355KX
- N7L1119KX
- N7M0088KX
- N7M0343KX
- N7M0477KRX
- N7M0509KX
- N7M0520KX
- N7M0521KX
- N8A0312KRX
- N8A0360KX
- N8A0433KX
- N8A0434KX
- N8A0435KX
- N8B0487KX
- N8C0026KX
- N8C0119KX
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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See all →- SevereMedtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
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- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
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- SevereMedtronic Endo GIA Stapler Recall Due to Missing Sled Component
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- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
FDA (Devices) · 2018-07-25
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