Reported Apr 7, 2021 · Ongoing
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D)
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?
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D)
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models |
| 2 | Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models |
| 3 | Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models |
| 4 | Compia family: Compia MRI CRT-D model |
| 5 | Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices). |
- Lot codes and dates
- 1)
- Viva familyMODEL
- NUMBER / NAME / GTIN
2,712 of 2,712 codes
SERIAL NUMBERS BLF244376HBLF243732HBLF244567HBLF243795HBLF244186HBLF244478HBLF243894HBLF243453HBLF244610HBLF244627HBLF243514HBLF242936HBLF244189HBLF243735HBLF243429HBLF244637HBLF235234HBLF242865HBLF243129HBLF243389HBLF242685HBLF243087HBLF243671HBLF243888HBLF243897HBLF244660HBLF242664HBLF242935HBLF243975HBLF243028HBLF243445HBLF243396HBLF243947HBLF243377HBLF242659HBLF244047HBLF243393HBLF243714HBLF242861HBLF243366HBLF243378HBLF242874HBLF243382HBLF243750HBLF242082HBLF242682HBLF243363HBLF243386HBLF243413HBLF243450HBLF243452HBLF243752HBLF243513HBLF243181HBLF242551HBLF243371HBLF243772HBLF241960HBLF243455HBLF243258H
- Amount recalled
- 238393 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.