Reported Jun 28, 2023 · Ongoing
ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
ICD COBALT VR MRI DF4Model Number DVPB3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178512
- Lot Serial Numbers
2,714 of 2,714 codes
RSF600012SRSF600254SRSF600591SRSF600655SRSF600822SRSF601247SRSF602653SRSF603908SRSF601102SRSF607914SRSF605967SRSF600633SRSF600649SRSF600867SRSF600868SRSF600869SRSF600872SRSF600873SRSF600874SRSF600875SRSF600876SRSF600878SRSF600880SRSF600883SRSF602930SRSF602991SRSF602998SRSF603002SRSF603003SRSF603013SRSF603018SRSF603019SRSF603022SRSF603026SRSF603027SRSF603030SRSF603032SRSF603033SRSF603034SRSF603035SRSF603036SRSF603736SRSF603737SRSF603741SRSF603742SRSF603744SRSF603746SRSF603747SRSF603749SRSF603754SRSF603755SRSF603756SRSF603758SRSF603759SRSF603762SRSF603763SRSF603764SRSF603799SRSF603802SRSF603804S
- Amount recalled
- 7048 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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