Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49
Summary
The FDA issued a Class II for Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graf by Medtronic Vascular, Inc.. Reason: During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover..
Details
Source
Device Recall
External ID
Z-2135-2021
Action Date
2021-08-04
Status
Ongoing
Category
device
Product Description
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
Lot/Code Info: Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882
Quantity Affected: 18 devices
Reason for Recall
During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Distribution
U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-07
Company
Santa Rosa, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Vascular, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Vascular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Vascular, Inc. have FDA actions?
Medtronic Vascular, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2135-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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