Reported Jun 28, 2023 · Ongoing
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; 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-DR DDBB1D4 EVERA XT IS1/DF4 USModel Number DDBB1D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720374
- Lot Serial Numbers
393 of 393 codes
BWB231977HBWB232204HBWB231981HBWB231888HBWB232232HBWB232076HBWB231876HBWB231908HBWB231979HBWB232244HBWB232310HBWB231918HBWB232114HBWB231867HBWB232361HBWB231879HBWB231847HBWB232311HBWB232048HBWB231915HBWB232272HBWB232281HBWB232164HBWB232142HBWB232316HBWB232027HBWB232321HBWB231976HBWB232046HBWB232357HBWB232185HBWB232233HBWB232334HBWB232378HBWB232411HBWB232049HBWB232218HBWB232097HBWB232326HBWB232156HBWB231855HBWB231858HBWB232032HBWB232106HBWB232015HBWB232260HBWB232284HBWB232328HBWB232059HBWB232018HBWB232037HBWB232043HBWB232092HBWB232112HBWB232125HBWB232144HBWB232175HBWB232179HBWB232181HBWB232190H
- Lot Serial Numbers
130 of 130 codes
BWB600022SBWB600096SBWB600123SBWB600095SBWB600107SBWB600069SBWB600221SBWB600141SBWB600101SBWB600028SBWB600068SBWB600218SBWB600224SBWB600045SBWB600092SBWB600046SBWB600031SBWB600033SBWB600035SBWB600036SBWB600037SBWB600038SBWB600110SBWB600213SBWB600049SBWB600061SBWB600048SBWB600064SBWB600177SBWB600127SBWB600132SBWB600126SBWB600144SBWB600216SBWB600024SBWB600025SBWB600082SBWB600214SBWB600215SBWB600055SBWB600137SBWB600077SBWB600174SBWB600210SBWB600062SBWB600013SBWB600166SBWB600148SBWB600014SBWB600015SBWB600034SBWB600052SBWB600087SBWB600172SBWB600053SBWB600054SBWB600071SBWB600078SBWB600233SBWB600059S
- Amount recalled
- 522 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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