Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Summary
The FDA issued a Class II for Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60- by Medtronic Inc.. Reason: Seal defects could compromise the ability of the product packaging to maintain sterility..
Details
Source
Device Recall
External ID
Z-0623-2024
Action Date
2024-01-10
Status
Completed
Category
device
Product Description
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Lot/Code Info: Lot number B644679, UDI-DI 00643169728974.
Quantity Affected: 1
Reason for Recall
Seal defects could compromise the ability of the product packaging to maintain sterility.
Distribution
US Nationwide distribution in the state of MN.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-20
Company
Plymouth, 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 84 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Inc. has 83 FDA actions in our database, including 46 recalls and 37 clearances.
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.) 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. have FDA actions?
Medtronic Inc. has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0623-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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