Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Summary
The FDA issued a Class II for Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Exp by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: There have been reports of stent migration..
Details
Source
Device Recall
External ID
Z-0464-2022
Action Date
2022-01-12
Status
Terminated
Category
device
Product Description
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Lot/Code Info: The IFU for all model numbers and serial numbers.
Quantity Affected: 21,653 devices
Reason for Recall
There have been reports of stent migration.
Distribution
Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-19
Company
Mounds View, MN
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 114 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 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 Inc., Cardiac Rhythm and Heart Failure (CRHF)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) have FDA actions?
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0464-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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