FDA Device recall Z-1781-2023
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1781-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
Reason
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Identifiers
| code_info | GTIN 00763000178222, Lot Serial numbers: RTP600502S, RTP602448S, RTP600549S, RTP600551S, RTP600553S, RTP600554S, RTP60…GTIN 00763000178222, Lot Serial numbers: RTP600502S, RTP602448S, RTP600549S, RTP600551S, RTP600553S, RTP600554S, RTP600555S, RTP601566S, RTP601569S, RTP602731S, RTP602733S, RTP601785S, RTP601786S, RTP601825S, RTP601826S, RTP601620S, RTP602203S, RTP602327S, RTP600744S, RTP600745S, RTP600762S, RTP601117S, RTP601187S, RTP601231S, RTP601906S, RTP603519S, RTP600475S, RTP600228S, RTP600308S, RTP600757S, RTP601116S, RTP601219S, RTP601221S, RTP601723S, RTP601724S, RTP601907S, RTP602117S, RTP602216S, RTP601572S, RTP602154S, RTP602038S, RTP600454S, RTP600670S, RTP601041S, RTP601066S, RTP601209S, RTP601801S, RTP600394S, RTP600397S, RTP600184S, RTP601049S, RTP601072S, RTP601822S, RTP600645S, RTP603289S, RTP603604S, RTP600559S, RTP600796S, RTP601834S, RTP600396S, RTP600738S, RTP600739S, RTP600740S, RTP600741S, RTP601589S, RTP601591S, RTP601595S, RTP601596S, RTP600148S, RTP600700S, RTP600627S, RTP601567S, RTP601186S, RTP601999S, RTP600819S, RTP601857S, RTP600576S, RTP600585S, RTP600779S, RTP600829S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1781-2023%22
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