FDA Device recall Z-1784-2023
CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ 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-1784-2023 |
| 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 QUAD MRI IS4 DF4, Model Number DTPB2QQ ; 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 00763000178178, Lot Serial numbers: RTK605097S, RTK600114S, RTK600141S, RTK600852S, RTK600858S, RTK601106S, RTK60…GTIN 00763000178178, Lot Serial numbers: RTK605097S, RTK600114S, RTK600141S, RTK600852S, RTK600858S, RTK601106S, RTK601201S, RTK602089S, RTK602953S, RTK603591S, RTK604031S, RTK600525S, RTK602527S, RTK606714S, RTK608837S, RTK608930S, RTK610777S, RTK600938S, RTK600939S, RTK600940S, RTK601391S, RTK601392S, RTK601393S, RTK601395S, RTK604983S, RTK604984S, RTK604033S, RTK606189S, RTK606293S, RTK606647S, RTK606683S, RTK606985S, RTK606988S, RTK607188S, RTK607189S, RTK607190S, RTK607191S, RTK607242S, RTK610835S, RTK603685S, RTK605333S, RTK601363S, RTK602275S, RTK602876S, RTK603055S, RTK600536S, RTK603273S, RTK603414S, RTK603912S, RTK604677S, RTK602444S, RTK602532S, RTK602533S, RTK602534S, RTK603360S, RTK603873S, RTK603874S, RTK603875S, RTK604155S, RTK604215S, RTK604626S, RTK607991S, RTK604065S, RTK604500S, RTK604161S, RTK610478S, RTK601877S, RTK606247S, RTK600611S, RTK609287S, RTK609288S, RTK609289S, RTK609290S, RTK609291S, RTK609293S, RTK609294S, RTK609295S, RTK609296S, RTK600247S, RTK600372S |
|---|
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-1784-2023%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.