FDA Device recall Z-1782-2023
CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4
- 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 DF4, Model Number DTPB2D4 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-1782-2023 |
| 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 DF4, Model Number DTPB2D4; 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 00763000178215, Lot Serial Numbers: RTO600161S, RTO600247S, RTO601140S, RTO601641S, RTO602045S, RTO602335S, RTO60…GTIN 00763000178215, Lot Serial Numbers: RTO600161S, RTO600247S, RTO601140S, RTO601641S, RTO602045S, RTO602335S, RTO602270S, RTO600314S, RTO601040S, RTO601383S, RTO600175S, RTO600229S, RTO600417S, RTO600458S, RTO600507S, RTO600650S, RTO601039S, RTO602060S, RTO603798S, RTO600463S, RTO601433S, RTO601826S, RTO601973S, RTO602476S, RTO601038S, RTO601148S, RTO601171S, RTO601248S, RTO602261S, RTO601481S, RTO600833S, RTO601285S, RTO601310S, RTO601556S, RTO600393S, RTO602484S, RTO600262S, RTO600681S, RTO601538S, RTO600380S, RTO600384S, RTO601944S, RTO602394S, RTO602445S, RTO600968S, RTO601037S, RTO601565S, RTO600218S, RTO601309S, RTO601311S, RTO601453S, RTO603333S, RTO600332S, RTO600493S, RTO601704S, RTO601798S, RTO601954S, RTO601983S, RTO602442S, RTO601808S, RTO601986S, RTO602037S, RTO600385S, RTO600435S, RTO601216S, RTO601220S, RTO601630S, RTO601735S, RTO601244S, RTO601307S, RTO601308S, RTO601043S, RTO602304S, RTO600445S, RTO600450S, RTO601513S, RTO601618S, RTO601942S, RTO600251S, RTO601520S |
|---|
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-1782-2023%22
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