COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Summary
The FDA issued a Class II for COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrill by Medtronic Inc.. Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing..
Details
Source
Device Recall
External ID
Z-2208-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product Description
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Lot/Code Info: GTIN: 00763000178512, Serial Numbers: RSF612135S, RSF612143S; GTIN: 00763000711375, Serial Numbers: RSF612097S, RSF612098S.
Quantity Affected: 4 units
Reason for Recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Distribution
Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-16
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 167 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-2208-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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