FDA Device recall Z-0038-2018

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be…

FDA Device
Class II
terminated
Published 2017-10-25

On 2017-10-25 the FDA classified a Class II recall of PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be… by St Jude Medical, citing new pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0038-2018
Classification	Class II
Status	terminated
Initiated	2017-08-28
Published	2017-10-25
Last updated	2026-09-13 11:54 UTC
Company	St Jude Medical
Distribution	n/a

Product

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

Reason

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Identifiers

code_info	Serial Numbers: 4794381 4913465 4913480 4907866 4909681 4909682 4913495 4909675 4909680 4909677 4909674 491… Serial Numbers: 4794381 4913465 4913480 4907866 4909681 4909682 4913495 4909675 4909680 4909677 4909674 4913482 4913489 4913487 4913472 4913458 4913133 4913137 4913477 4909678 4913469 4913459 4913498 4909347 4913492 4913139 4908522 4909679 4909350 4909345 4909348 4909190 4909189 4909188 4909186 4909349 4908662 4909182 4909184 4909183 4909346 4909344 4909185 4909352 4909351 4909187 4913155 4913493 4913844 4913143 4913148 4913166 4913153 4913167 4913163 4913158 4913140 4913466 4913164 4913150 4913125 4913131 4913159 4913162 4913160 4913461 4913146 4913500 4915969 4915951 4915954 4915947 4915958 4915968 4915961 4915949 4913468 4915957 4913842 4913471 4913475 4913481 4913499 4913147 4913496 4913479 4913843 4913132 4915955 4913476 4913152 4913501 4913470 4913462 4913463 4913138 4913134 4913460 4913124 4913473 4913145 4913478 4913464 4913467 4913491 4913483 4913484 4913485 4913486 49

code_info

Serial Numbers: 4794381 4913465 4913480 4907866 4909681 4909682 4913495 4909675 4909680 4909677 4909674 491…

Serial Numbers: 4794381 4913465 4913480 4907866 4909681 4909682 4913495 4909675 4909680 4909677 4909674 4913482 4913489 4913487 4913472 4913458 4913133 4913137 4913477 4909678 4913469 4913459 4913498 4909347 4913492 4913139 4908522 4909679 4909350 4909345 4909348 4909190 4909189 4909188 4909186 4909349 4908662 4909182 4909184 4909183 4909346 4909344 4909185 4909352 4909351 4909187 4913155 4913493 4913844 4913143 4913148 4913166 4913153 4913167 4913163 4913158 4913140 4913466 4913164 4913150 4913125 4913131 4913159 4913162 4913160 4913461 4913146 4913500 4915969 4915951 4915954 4915947 4915958 4915968 4915961 4915949 4913468 4915957 4913842 4913471 4913475 4913481 4913499 4913147 4913496 4913479 4913843 4913132 4915955 4913476 4913152 4913501 4913470 4913462 4913463 4913138 4913134 4913460 4913124 4913473 4913145 4913478 4913464 4913467 4913491 4913483 4913484 4913485 4913486 49

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-0038-2018%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.