CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report
Medtronic Cobalt HF Quad Crt-d MRI SureScan recalled
Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) is recalling Medtronic Cobalt HF Quad Crt-d MRI SureScan, distributed in Georgia, New Jersey, Pennsylvania. The recall was initiated on 15 Nov 2020 and the FDA has classified it as Class II.
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-0926-2021
- FDA event ID
- 86887
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf), Mounds View, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Nov 2020
- FDA classified
- 26 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 15 Nov 2020 | Recall initiated by company | |
| 26 Jan 2021 | Classified by FDA | +72 days |
| 3 Feb 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Where it was distributed
Distribution to US states of GA, PA, NJ, and France
Questions about this recall
Why was it recalled?
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Which lots are affected?
Serial Numbers: RTK602501S, RTK602506S
Where was it sold?
Distribution to US states of GA, PA, NJ, and France
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 86887This product is part of a recall event; the main page for the event is Medtronic Cobalt DR MRI SureScan DDPB3D1 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medtronic Cobalt DR MRI SureScan DDPB3D1 recalled | Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) | Device Malfunction | GA, NJ, PA | |
| CLASS II | Medtronic Cobalt HF Crt-d MRI SureScan DTPB2D1 recalled | Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) | Device Malfunction | GA, NJ, PA |
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