Reported Feb 28, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria 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), Claria MRI. Labeled as the following
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Claria MRI CRT-D DF1 (Product No. DTMA1D1) |
| 2 | Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION |
| 3 | Claria MRI CRT-D DF4 (Product No. DTMA1D4) |
| 4 | Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) 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
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 0064316970577700643169929531UDI 00643169705777 (Serial No. RPT200245H) (EXPANSION Serial No. RPT201653H, RPT200308H, RPT201033H, RPT202625H, RPT201913H, RPT202623H, RPT202624H, RPT202627H, RPT202626H), 00643169929531 (Serial No. RPT202182H) 2 0064316954336200643169929562Product No. DTMA1QQ: UDI 00643169543362 (Serial No. RPA202057H) (EXPANSION: Serial No. RPA200224H, RPA200472H, RPA200673H, RPA201732H, RPA201733H, RPA202258H, RPA202454H, RPA202455H, RPA202649H, RPA202650H, RPA202651H, RPA202652H, RPA202653H, RPA203381H, RPA203416H, RPA203546H, RPA203547H, RPA204428H, RPA204605H, RPA204606H, RPA201333H, RPA202259H), 00643169929562 (Serial No. RPA204495H) 3 00643169543416EXPANSION: c. Product No. DTMA1D4: UDI 00643169543416 (Serial No. RPC200266H, RPC200772H, RPC200830H, RPC201028H, RPC201030H, RPC201382H, RPC201056H, RPC201383H) 4 00643169705760Product No. DTMA1Q1: UDI 00643169705760 (Serial No. RPS200939H) - 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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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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