FDA Device recall Z-2323-2018

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195

FDA Device
Class II
terminated
Published 2018-07-04

On 2018-07-04 the FDA classified a Class II recall of Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195 by St Jude Medical, citing the firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2323-2018
Classification	Class II
Status	terminated
Initiated	2018-04-16
Published	2018-07-04
Last updated	2026-09-13 11:54 UTC
Company	St Jude Medical
Distribution	US

Product

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

Reason

The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

Identifiers

code_info	Serial #: 1062415 584948 584973 844882 1059669 585788 844881 585793 585797 844884 585785 585777 1059667 5… Serial #: 1062415 584948 584973 844882 1059669 585788 844881 585793 585797 844884 585785 585777 1059667 585796 584135 584051 584008 584133 583946 583999 583991 584136 583996 583982 583943 584078 583980 584005 584007 584106 583989 584128 583950 584028 584060 584115 583968 584064 584067 584069 584029 584077 584024 584116 584058 584044 584111 583930 583964 584065 583994 584032 583966 583990 583979 584062 568379 583959 584056 568359 584019 584015 584126 584014 583978 583975 584038 584050 584013 584049 583954 584127 584031 584080 584119 568348 584071 584070 584021 584000 583957 584122 584083 583987 584081 584035 583976 584072 583997 583985 584040 583963 584017 584054 584026 584002 568380 584068 584034 583972 584043 584023 583981 584125 584001 585635 585143 585420 585127 585405 585289 585400 585422 585379 585370 585442 585319 585357 585129 585423 585414 585445 585435 58

code_info

Serial #: 1062415 584948 584973 844882 1059669 585788 844881 585793 585797 844884 585785 585777 1059667 5…

Serial #: 1062415 584948 584973 844882 1059669 585788 844881 585793 585797 844884 585785 585777 1059667 585796 584135 584051 584008 584133 583946 583999 583991 584136 583996 583982 583943 584078 583980 584005 584007 584106 583989 584128 583950 584028 584060 584115 583968 584064 584067 584069 584029 584077 584024 584116 584058 584044 584111 583930 583964 584065 583994 584032 583966 583990 583979 584062 568379 583959 584056 568359 584019 584015 584126 584014 583978 583975 584038 584050 584013 584049 583954 584127 584031 584080 584119 568348 584071 584070 584021 584000 583957 584122 584083 583987 584081 584035 583976 584072 583997 583985 584040 583963 584017 584054 584026 584002 568380 584068 584034 583972 584043 584023 583981 584125 584001 585635 585143 585420 585127 585405 585289 585400 585422 585379 585370 585442 585319 585357 585129 585423 585414 585445 585435 58

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2018%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.