RecallRadar

FDA Device recall Z-1771-2023

CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1 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

AgencyFDA Device
Recall numberZ-1771-2023
ClassificationClass I
Statusongoing
Initiated2023-05-10
Published2023-06-28
Last updated2026-09-13 11:56 UTC
CompanyMedtronic Cardiac Rhythm And Heart Failure Crhf
DistributionUS

Product

CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; 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 00643169837652, Lot Serial Numbers: RPR605458S, RPR606698S, RPR605664S, RPR602262S, RPR601954S, RPR602352S, RPR60…GTIN 00643169837652, Lot Serial Numbers: RPR605458S, RPR606698S, RPR605664S, RPR602262S, RPR601954S, RPR602352S, RPR602691S, RPR602236S, RPR601128S, RPR601184S, RPR601760S, RPR603209S, RPR603275S, RPR603699S, RPR605742S, RPR605761S, RPR605767S, RPR605779S, RPR605784S, RPR605787S, RPR605804S, RPR605808S, RPR605811S, RPR605818S, RPR606116S, RPR606117S, RPR606122S, RPR606123S, RPR606127S, RPR606128S, RPR606138S, RPR606140S, RPR606272S, RPR606276S, RPR606278S, RPR606279S, RPR606285S, RPR606289S, RPR607179S, RPR607180S, RPR607181S, RPR607182S, RPR607183S, RPR607184S, RPR607185S, RPR607187S, RPR607188S, RPR607525S, RPR606331S, RPR607064S, RPR607604S, RPR607373S, RPR604676S, RPR605390S, RPR605391S, RPR607439S, RPR602589S, RPR602608S, RPR602612S, RPR602645S, RPR602882S, RPR602940S, RPR602941S, RPR602944S, RPR602946S, RPR602951S, RPR603067S, RPR603252S, RPR603254S, RPR603744S, RPR603758S, RPR603759S, RPR603891S, RPR603892S, RPR603894S, RPR604007S, RPR604025S, RPR604173S, RPR604233S, RPR604234S

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-1771-2023%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.