CLASS I Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) recalled
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI, distributed nationwide in the US. The recall was initiated on 19 Dec 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0586-2018
- FDA event ID
- 78888
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Dec 2017
- FDA classified
- 19 Apr 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 19 Dec 2017 | Recall initiated by company | |
| 28 Feb 2018 | Published in enforcement report | +71 days |
| 19 Apr 2018 | Classified by FDA | +50 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Product as listed by the FDA
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. 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).
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Is Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI recalled?
Yes. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI on 19 Dec 2017. The recall is Class I and its status is Terminated. Recall number Z-0586-2018.
Why was it recalled?
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Which lots are affected?
a. Product No. DTMA1D1: UDI 00643169705777 (Serial No. RPT200245H) (EXPANSION Serial No. RPT201653H, RPT200308H, RPT201033H, RPT202625H, RPT201913H, RPT202623H, RPT202624H, RPT202627H, RPT202626H), 00643169929531 (Serial No. RPT202182H); b. Product 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); EXPANSION: c. Product No. DTMA1D4: UDI 00643169543416 (Serial No. RPC200266H, RPC200772H, RPC200830H, RPC201028H, RPC201030H, RPC201382H, RPC201056H, RPC201383H); d. Product No. DTMA1Q1: UDI 00643169705760 (Serial No. RPS200939H)
Where was it sold?
US Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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