FDA Device recall Z-1762-2023
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4 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-1762-2023 |
| 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 DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; 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 00643169720718, Lot Serial Numbers: RPJ204877H, RPJ205009H, RPJ205996H, RPJ206294H, RPJ205851H, RPJ206501H, RPJ20…GTIN 00643169720718, Lot Serial Numbers: RPJ204877H, RPJ205009H, RPJ205996H, RPJ206294H, RPJ205851H, RPJ206501H, RPJ205969H, RPJ205051H, RPJ206429H, RPJ205893H, RPJ205344H, RPJ206237H, RPJ206208H, RPJ206032H, RPJ206082H, RPJ206104H, RPJ205080H, RPJ205234H, RPJ206059H, RPJ205438H, RPJ206376H, RPJ205287H, RPJ205509H, RPJ206342H, RPJ205891H, RPJ204872H, RPJ204899H, RPJ204933H, RPJ204973H, RPJ205142H, RPJ205777H, RPJ205989H, RPJ206295H, RPJ205059H, RPJ205148H, RPJ205732H, RPJ205873H, RPJ206504H, RPJ205500H, RPJ206357H, RPJ204876H, RPJ206359H, RPJ206369H, RPJ205623H, RPJ206218H, RPJ205743H, RPJ206172H, RPJ204917H, RPJ205981H, RPJ205041H, RPJ205073H, RPJ205235H, RPJ205246H, RPJ205279H, RPJ206045H, RPJ205880H, RPJ206050H, RPJ206207H, RPJ205049H, RPJ204888H, RPJ205038H, RPJ205039H, RPJ205047H, RPJ205053H, RPJ205054H, RPJ205333H, RPJ205334H, RPJ205349H, RPJ205420H, RPJ205471H, RPJ205510H, RPJ205593H, RPJ205717H, RPJ205727H, RPJ205982H, RPJ206074H, RPJ206186H, RPJ206234H, RPJ204891H, RPJ205317H |
|---|
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-1762-2023%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.