Reported Feb 28, 2018 · Terminated
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1);…
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 (ICDs), Visia AF
- Labeled asa. Visia AF VR ICD DF1 (Product No. DVAB1D1)
- EXPANSIONb. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices)
- Lot codes and dates
- a. Product No
- DVAB1D1UDI 00643169566347 (Serial No
- BWN201126H) (EXPANSION
Serial No. BWN202016HBWN202327HBWN202334HBWN202335H)
- EXPANSIONb. Product No
- DVAB1D4
UDI 00643169566354 (Serial No. BWP201614HBWP201658HBWP201660HBWP201669HBWP201782HBWP201783H)00643169929760 (Serial No. BWP201661H)
- Amount recalled
- 951 devices total
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Using this product could cause serious injury, illness or death — stop using it now.
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