FDA Device recall Z-1490-2022
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DT…
- FDA Device
- Class I
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class I recall of Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DT… by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1490-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-06-22 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
Reason
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Identifiers
| code_info | a. Model Numbers: DTPC2D4: GTIN 00763000178291, Serial Numbers: RTW600120S, RTW600307S; GTIN 00763000178314, Seri…a. Model Numbers: DTPC2D4: GTIN 00763000178291, Serial Numbers: RTW600120S, RTW600307S; GTIN 00763000178314, Serial Numbers: RTW600018S, RTW600020S, RTW600022S, RTW600025S, RTW600027S, RTW600028S, RTW600029S, RTW600032S, RTW600033S, RTW600034S, RTW600038S, RTW600040S, RTW600041S, RTW600045S, RTW600232S, RTW600316S, RTW600318S, RTW600321S, RTW600324S, RTW600334S, RTW600335S, RTW600336S, RTW600340S, RTW600341S, RTW600344S, RTW600351S, RTW600356S, RTW600359S, RTW600360S, RTW600361S, RTW600364S, RTW600387S, RTW600388S, RTW600389S, RTW600390S, RTW600391S, RTW600392S, RTW600393S, RTW600394S, RTW600395S, RTW600396S, RTW600397S, RTW600398S, RTW600399S, RTW600400S, RTW600401S, RTW600403S, RTW600404S, RTW600405S, RTW600408S, RTW600410S, RTW600412S, RTW600413S, RTW600415S, RTW600417S, RTW600419S, RTW600420S, RTW600421S, RTW600422S, RTW600425S, RTW600426S, RTW600427S, RTW600428S, RTW600430S, RTW600433S, RTW600436S, RTW600441S, RTW600444S, RTW600445S, RTW600449S, RTW600450S, RTW600452S, RTW6 |
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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-1490-2022%22
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