Reported Feb 28, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI 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?
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI
- Labeled as the followinga. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) 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
- DTMC1D1UDI 00643169705807 (Serial No. RPW200289H); b. Product No
- DTMC1QQUDI 00643169565272 (Serial No
- RPL201034H) (EXPANSION
Serial No. RPL200052HRPL200534HRPL201039HRPL201059HRPL201235HRPL201236HRPL201454HRPL201645HRPL201664HRPL201234H)
- 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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