Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Summary
The FDA issued a Class II for Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Th by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements..
Details
Source
Device Recall
External ID
Z-1480-2022
Action Date
2022-08-03
Status
Ongoing
Category
device
Product Description
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Lot/Code Info: GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Quantity Affected: 3 units
Reason for Recall
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Distribution
US Nationwide distribution in the states of Indiana and CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-11-05
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 163 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-1480-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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