FDA Device recall Z-1764-2023
CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ 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-1764-2023 |
| 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 DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; 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 00643169720671, Lot Serial Numbers: RPE221706H, RPE221707H, RPE221708H, RPE221712H, RPE221714H, RPE221715H, RPE22…GTIN 00643169720671, Lot Serial Numbers: RPE221706H, RPE221707H, RPE221708H, RPE221712H, RPE221714H, RPE221715H, RPE222453H, RPE222479H, RPE222484H, RPE222493H, RPE223082H, RPE223083H, RPE223085H, RPE223086H, RPE223087H, RPE224112H, RPE224115H, RPE224116H, RPE224117H, RPE221282H, RPE222157H, RPE222778H, RPE222899H, RPE223002H, RPE223681H, RPE222052H, RPE224096H, RPE224699H, RPE225223H, RPE225228H, RPE225260H, RPE226241H, RPE226280H, RPE226296H, RPE226578H, RPE226614H, RPE226861H, RPE227698H, RPE227755H, RPE223791H, RPE226062H, RPE221213H, RPE221541H, RPE221727H, RPE221823H, RPE222060H, RPE222451H, RPE222481H, RPE222548H, RPE222618H, RPE222760H, RPE222970H, RPE222978H, RPE223026H, RPE224464H, RPE224543H, RPE224745H, RPE225324H, RPE225723H, RPE225724H, RPE225729H, RPE225737H, RPE220952H, RPE220957H, RPE220960H, RPE221018H, RPE221039H, RPE221251H, RPE221335H, RPE221336H, RPE222358H, RPE223216H, RPE223219H, RPE224021H, RPE224024H, RPE224026H, RPE224029H, RPE224031H, RPE224032H, RPE224827H |
|---|
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-1764-2023%22
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