FDA Device recall Z-1763-2023
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1 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-1763-2023 |
| 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 DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; 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 00643169837683, Lot Serial Numbers: RPU202561H, RPU202848H, RPU202573H, RPU203658H, RPU203285H, RPU203317H, RPU20…GTIN 00643169837683, Lot Serial Numbers: RPU202561H, RPU202848H, RPU202573H, RPU203658H, RPU203285H, RPU203317H, RPU203431H, RPU203502H, RPU203716H, RPU203301H, RPU203534H, RPU203203H, RPU203261H, RPU203298H, RPU203066H, RPU203286H, RPU202440H, RPU202452H, RPU202505H, RPU202580H, RPU202588H, RPU202610H, RPU202614H, RPU202616H, RPU202617H, RPU202619H, RPU202624H, RPU202690H, RPU202707H, RPU202829H, RPU202831H, RPU202834H, RPU202914H, RPU203010H, RPU203011H, RPU203012H, RPU203013H, RPU203017H, RPU203018H, RPU203019H, RPU203021H, RPU203159H, RPU203161H, RPU203205H, RPU203486H, RPU203494H, RPU203242H, RPU203690H, RPU203709H, RPU203138H, RPU202362H, RPU202206H, RPU202274H, RPU202493H, RPU202529H, RPU202874H, RPU203234H, RPU203405H, RPU202258H, RPU202269H, RPU202642H, RPU202948H, RPU203105H, RPU203278H, RPU203104H, RPU202960H, RPU202775H, RPU203122H, RPU203648H, RPU202139H, RPU202324H, RPU202745H, RPU202577H, RPU203031H, RPU203300H, RPU202814H, RPU202388H, RPU202818H, RPU203357H, RPU203517H |
|---|
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-1763-2023%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.