FDA Device recall Z-1773-2023
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ 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-1773-2023 |
| 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 DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; 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 00643169720688, Lot Serial numbers: RPF622750S, RPF618290S, RPF616459S, RPF619209S, RPF620414S, RPF613519S, RPF61…GTIN 00643169720688, Lot Serial numbers: RPF622750S, RPF618290S, RPF616459S, RPF619209S, RPF620414S, RPF613519S, RPF617908S, RPF607263S, RPF605123S, RPF606355S, RPF607965S, RPF607966S, RPF607968S, RPF607969S, RPF610837S, RPF612639S, RPF613175S, RPF613176S, RPF614678S, RPF616130S, RPF616164S, RPF616174S, RPF616577S, RPF616578S, RPF617220S, RPF617584S, RPF617585S, RPF617586S, RPF619084S, RPF619475S, RPF619476S, RPF619729S, RPF609798S, RPF609803S, RPF609809S, RPF610924S, RPF610929S, RPF610935S, RPF610938S, RPF610947S, RPF614776S, RPF614782S, RPF618353S, RPF618354S, RPF618355S, RPF618356S, RPF618357S, RPF618358S, RPF618361S, RPF618362S, RPF608224S, RPF608225S, RPF611060S, RPF614821S, RPF616957S, RPF617031S, RPF618423S, RPF618476S, RPF619798S, RPF620332S, RPF621332S, RPF622094S, RPF620132S, RPF621989S, RPF615594S, RPF615595S, RPF620714S, RPF623023S, RPF612794S, RPF612795S, RPF612796S, RPF612799S, RPF612800S, RPF612801S, RPF612802S, RPF612829S, RPF612831S, RPF612833S, RPF613375S, RPF613376S |
|---|
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-1773-2023%22
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