Reported Feb 28, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia 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?
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Amplia MRI CRT-D DF4 (Product No. DTMB1D4) |
| 2 | Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1) |
| 3 | Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION |
| 4 | Amplia MRI CRT-D DF1 (Product No. DTMB1D1) 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
- DTMB1D4UDI 00643169543430 (Serial No. RPJ201956H
- RPJ202805H) (EXPANSION
Serial No. RPJ201660HRPJ201661HRPJ201972HRPJ202145HRPJ202821HRPJ203208HRPJ203209HRPJ203826H)b. Product No
- DTMB1Q1UDI 00643169705784 (Serial No
- RPU201108H) (EXPANSION
Serial No. RPU201289HRPU201290HRPU201291HRPU201292HRPU201293HRPU201295HRPU201296HRPU201297HRPU201298HRPU201299HRPU201300HRPU201301HRPU201302HRPU201303HRPU201305HRPU201306HRPU201287HRPU201288HRPU201619HRPU201621HRPU201635HRPU201304H)c. Product No
- DTMB1QQ
UDI 00643169929647 (Serial No. RPE219331HRPE218183H)00643169543386 (Serial No. RPE201417HRPE204789HRPE206207HRPE207850HRPE209095H
- RPE212027H) (EXPANSION
77 of 77 codes
Serial No. RPE215624HRPE217014HRPE200352HRPE200394HRPE201115HRPE201328HRPE202133HRPE202941HRPE203460HRPE203771HRPE203998HRPE204209HRPE204790HRPE204791HRPE204792HRPE205432HRPE206879HRPE206886HRPE208041HRPE208241HRPE208355HRPE208369HRPE208613HRPE209037HRPE209093HRPE209135HRPE209190HRPE209194HRPE209553HRPE210227HRPE210228HRPE210672HRPE210673HRPE210734HRPE210841HRPE210844HRPE210869HRPE210870HRPE210874HRPE210875HRPE211011HRPE211012HRPE211731HRPE211732HRPE211734HRPE211736HRPE211820HRPE211858HRPE211859HRPE213564HRPE214135HRPE214544HRPE214545HRPE214546HRPE215260HRPE215628HRPE216247HRPE217013HRPE217332HRPE217335H
- EXPANSIONd. Product No
- DTMB1D1
UDI 00643169705791 (Serial No. RPV200926HRPV201075HRPV201757HRPV201758H)
- 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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