FDA Device recall Z-1766-2023

CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4 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-1766-2023
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 DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; 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 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK60… GTIN 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK607156S, RPK607510S, RPK606721S, RPK606379S, RPK606753S, RPK603895S, RPK607997S, RPK608001S, RPK608115S, RPK602608S, RPK602842S, RPK602915S, RPK603155S, RPK603438S, RPK603475S, RPK604209S, RPK604230S, RPK604885S, RPK605001S, RPK605994S, RPK606046S, RPK606664S, RPK607134S, RPK608665S, RPK604002S, RPK604373S, RPK605499S, RPK605680S, RPK603963S, RPK607543S, RPK607544S, RPK607943S, RPK608088S, RPK608203S, RPK607149S, RPK607416S, RPK607418S, RPK607615S, RPK608212S, RPK608297S, RPK608298S, RPK609062S, RPK604646S, RPK605555S, RPK605685S, RPK606797S, RPK604171S, RPK605262S, RPK605291S, RPK605292S, RPK606475S, RPK607086S, RPK603372S, RPK603375S, RPK603380S, RPK603962S, RPK604174S, RPK604351S, RPK604536S, RPK604651S, RPK604654S, RPK604869S, RPK604972S, RPK604973S, RPK605109S, RPK605214S, RPK605233S, RPK605272S, RPK606024S, RPK606053S, RPK606141S, RPK606473S, RPK606792S, RPK606817S

code_info

GTIN 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK60…

GTIN 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK607156S, RPK607510S, RPK606721S, RPK606379S, RPK606753S, RPK603895S, RPK607997S, RPK608001S, RPK608115S, RPK602608S, RPK602842S, RPK602915S, RPK603155S, RPK603438S, RPK603475S, RPK604209S, RPK604230S, RPK604885S, RPK605001S, RPK605994S, RPK606046S, RPK606664S, RPK607134S, RPK608665S, RPK604002S, RPK604373S, RPK605499S, RPK605680S, RPK603963S, RPK607543S, RPK607544S, RPK607943S, RPK608088S, RPK608203S, RPK607149S, RPK607416S, RPK607418S, RPK607615S, RPK608212S, RPK608297S, RPK608298S, RPK609062S, RPK604646S, RPK605555S, RPK605685S, RPK606797S, RPK604171S, RPK605262S, RPK605291S, RPK605292S, RPK606475S, RPK607086S, RPK603372S, RPK603375S, RPK603380S, RPK603962S, RPK604174S, RPK604351S, RPK604536S, RPK604651S, RPK604654S, RPK604869S, RPK604972S, RPK604973S, RPK605109S, RPK605214S, RPK605233S, RPK605272S, RPK606024S, RPK606053S, RPK606141S, RPK606473S, RPK606792S, RPK606817S

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-1766-2023%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.