FDA Device recall Z-1783-2023
CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1
- 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 DF1, Model Number DTPB2Q1 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-1783-2023 |
| 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 DF1, Model Number DTPB2Q1 ; 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 00763000178185, Lot Serial Numbers: RTL600234S, RTL600470S, RTL601046S, RTL601412S, RTL601722S, RTL601669S, RTL60…GTIN 00763000178185, Lot Serial Numbers: RTL600234S, RTL600470S, RTL601046S, RTL601412S, RTL601722S, RTL601669S, RTL601698S, RTL600323S, RTL600660S, RTL600661S, RTL601185S, RTL601206S, RTL601213S, RTL601406S, RTL601445S, RTL601446S, RTL600649S, RTL600650S, RTL601428S, RTL601017S, RTL600219S, RTL601076S, RTL601544S, RTL602514S, RTL600684S, RTL601477S, RTL601865S, RTL600638S, RTL600639S, RTL600640S, RTL600641S, RTL600642S, RTL600643S, RTL601151S, RTL601154S, RTL601156S, RTL601160S, RTL601161S, RTL601162S, RTL601163S, RTL601164S, RTL601165S, RTL601167S, RTL601170S, RTL600209S, RTL600835S, RTL600997S, RTL600519S, RTL601459S, RTL601689S, RTL600978S, RTL601540S, RTL601880S, RTL600522S, RTL601510S, RTL600949S, RTL601624S, RTL601372S, RTL600810S, RTL600266S, RTL600281S, RTL600528S, RTL600596S, RTL600654S, RTL600777S, RTL600813S, RTL600841S, RTL600846S, RTL601563S, RTL601021S, RTL601208S, RTL600243S, RTL600244S, RTL600245S, RTL600533S, RTL601085S, RTL601148S, RTL601373S, RTL601231S, RTL601864S |
|---|
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-1783-2023%22
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