Reported Jun 28, 2023 · Ongoing
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; 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 CROME DR MRI IS1 DF4Model Number DDPC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178437
- Lot Serial Numbers
577 of 577 codes
RSQ600736SRSQ600745SRSQ600905SRSQ600975SRSQ601406SRSQ600113SRSQ600114SRSQ600115SRSQ600255SRSQ600256SRSQ600257SRSQ600258SRSQ600261SRSQ600740SRSQ601122SRSQ601137SRSQ601177SRSQ601178SRSQ601179SRSQ601181SRSQ601227SRSQ601228SRSQ601229SRSQ601375SRSQ601377SRSQ600055SRSQ600163SRSQ600164SRSQ600936SRSQ601151SRSQ600049SRSQ600051SRSQ600713SRSQ600991SRSQ601411SRSQ601416SRSQ600218SRSQ600237SRSQ600679SRSQ600712SRSQ600723SRSQ600772SRSQ600074SRSQ600090SRSQ600012SRSQ600053SRSQ600811SRSQ600843SRSQ600912SRSQ600913SRSQ600195SRSQ600894SRSQ600981SRSQ600748SRSQ601201SRSQ601378SRSQ601479SRSQ601490SRSQ600782SRSQ600665S
- Lot Serial Numbers
1,442 of 1,442 codes
RSQ601381SRSQ601864SRSQ601577SRSQ601725SRSQ602374SRSQ602588SRSQ600669SRSQ601974SRSQ602244SRSQ602281SRSQ602350SRSQ602191SRSQ602565SRSQ602566SRSQ602118SRSQ602139SRSQ601767SRSQ602490SRSQ601983SRSQ601745SRSQ602226SRSQ602536SRSQ602320SRSQ602321SRSQ602370SRSQ601884SRSQ601925SRSQ601987SRSQ602234SRSQ602235SRSQ602271SRSQ602280SRSQ600290SRSQ600459SRSQ600435SRSQ601093SRSQ600582SRSQ601380SRSQ600593SRSQ600024SRSQ600489SRSQ600494SRSQ600554SRSQ601029SRSQ601032SRSQ601394SRSQ601702SRSQ600047SRSQ600027SRSQ600031SRSQ600042SRSQ600585SRSQ600602SRSQ601042SRSQ601396SRSQ601414SRSQ601437SRSQ601580SRSQ601621SRSQ601880S
- Amount recalled
- 2018 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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