FDA Device recall Z-1488-2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4,…
- FDA Device
- Class I
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class I recall of Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4,… 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-1488-2022 |
| 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
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
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: DTPB2D4: GTIN 00763000178215, Serial Numbers: RTO600239S, RTO600280S, RTO600409S, RTO600468S, RT…a. Model Numbers: DTPB2D4: GTIN 00763000178215, Serial Numbers: RTO600239S, RTO600280S, RTO600409S, RTO600468S, RTO600544S, RTO600701S, RTO600712S, RTO601012S, RTO601031S, RTO601113S, RTO601150S, RTO601156S, RTO601205S, RTO601223S, RTO601549S, RTO601612S, RTO601620S, RTO601784S, RTO601793S, RTO601819S, RTO601823S, RTO601830S, RTO601845S, RTO601846S, RTO601858S, RTO601860S, RTO601862S, RTO601891S, RTO601905S, RTO601945S, RTO601960S, RTO601965S, RTO601986S, RTO602000S, RTO602002S, RTO602029S, RTO602031S, RTO602056S, RTO602107S, RTO602110S, RTO602116S, RTO602159S, RTO602164S, RTO602173S, RTO602183S, RTO602224S, RTO602260S, RTO602261S, RTO602266S, RTO602297S, RTO602303S, RTO602308S, RTO602311S, RTO602324S, RTO602326S, RTO602330S, RTO602331S, RTO602333S, RTO602336S, RTO602340S, RTO602354S, RTO602362S, RTO602372S, RTO602375S, RTO602427S, RTO602431S, RTO602435S, RTO602447S, RTO602452S, RTO602468S, RTO602479S, RTO602487S, RTO602493S, RTO602513S, RTO602516S, RTO602520S, RTO602524S, RTO6025 |
|---|
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-1488-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.