Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Summary
The FDA issued a Class II for Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For by Medtronic Vascular, Inc.. Reason: Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr..
Details
Source
Device Recall
External ID
Z-1976-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Lot/Code Info: Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;
Quantity Affected: 3 devices
Reason for Recall
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Distribution
U.S. Nationwide distribution in the state of GA. O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-28
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 52 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-1976-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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