CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report
Cobalt Implantable Cardioverter Defibrillators recalled
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy, distributed nationwide in the US. The recall was initiated on 5 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-1480-2022
- FDA event ID
- 90429
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Nov 2020
- FDA classified
- 28 Jul 2022
- Reported
- 3 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Device type
- Pacemakers & Defibrillators
Timeline
| 5 Nov 2020 | Recall initiated by company | |
| 28 Jul 2022 | Classified by FDA | +630 days |
| 3 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Where it was distributed
US Nationwide distribution in the states of Indiana and CA.
Questions about this recall
Is Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy recalled?
Yes. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy on 5 Nov 2020. The recall is Class II and its status is Ongoing. Recall number Z-1480-2022.
Why was it recalled?
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Which lots are affected?
GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Where was it sold?
US Nationwide distribution in the states of Indiana and CA.
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 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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