The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0657-2022·Announced 2022-03-02

Medtronic Endurant Stent Graft Systems: Taper Tip Detachment Risk

Certain Medtronic Endurant stent graft systems may have taper tips that detach from the delivery system during implant procedures, potentially requiring secondary surgical intervention.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a manufacturing defect in stent graft taper tip assemblies with potential for detachment during implant procedures. Per the rubric, this qualifies as a risk-of-harm medical device where injury has not yet been reported, warranting a score of 3 (High).

Plain-English summary

Medtronic Vascular, Inc. is recalling certain batches of Endurant, Endurant II, and Endurant IIs Stent Graft Systems due to a manufacturing defect in the taper tip assemblies. The affected devices, which were distributed worldwide including throughout the United States, are used to treat infrarenal abdominal aortic aneurysms and aortoiliac aneurysms using an endovascular approach. Approximately 14,629 devices are affected.

Stent graft systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment during the implant procedure may necessitate a secondary intervention to attempt removal of the taper tip, either by endovascular retrieval or surgical conversion. The taper tip may alternatively be intentionally left behind in the patient at the physician's discretion if it cannot be easily removed.

Patients who received one of the affected devices should contact their healthcare provider for guidance. Healthcare providers should verify the affected serial numbers among their implanted and stored devices and determine appropriate actions based on clinical assessment.

The recalled product

Product
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE…
Manufacturer
Medtronic Vascular, Inc.
Category
Medical Device — Cardiovascular / Stent Graft
Hazard
Affected units
14,629

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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