Reported Feb 28, 2018 · Terminated
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following
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 MRI. Labeled as the following
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1) |
| 2 | Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION |
| 3 | Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1) |
| 4 | Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) 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
- DVFB1D1UDI 00643169717213 (Serial No
- CWG200402H) (EXPANSION
Serial No. CWG200403HCWG200404HCWG200406HCWG200897HCWG200898HCWG202225HCWG202244HCWG202762HCWG203250HCWG203455HCWG200147HCWG200899HCWG202761H)b. Product No
- DVFB1D4
UDI 00643169566422 (Serial No. PKX202448HPKX205417HPKX205779H
- PKX209277H) (EXPANSION
87 of 87 codes
Serial No. PKX211818HPKX201092HPKX201561HPKX201910HPKX202355HPKX202386HPKX202879HPKX202881HPKX202882HPKX202883HPKX202884HPKX202885HPKX202960HPKX203135HPKX203209HPKX203946HPKX203947HPKX203950HPKX204060HPKX204170HPKX204372HPKX204490HPKX204625HPKX204629HPKX204640HPKX205178HPKX205179HPKX205181HPKX205239HPKX205240HPKX205268HPKX205269HPKX205659HPKX205660HPKX205661HPKX205662HPKX205663HPKX205665HPKX205666HPKX205673HPKX205774HPKX206142HPKX206740HPKX206996HPKX207013HPKX207619HPKX207870HPKX208254HPKX209305HPKX210996HPKX211165HPKX211167HPKX211168HPKX211169HPKX211170HPKX211195HPKX211196HPKX211198HPKX211222HPKX211223H
- EXPANSIONc. Product No
- DVFC3D1UDI 00643169717206 (Serial No. CWJ200155H); d. Product No
- DVFC3D4UDI 00643169566446 (Serial No. PMX200139H)
- 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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