FDA Device recall Z-0036-2018
PM 1250 and PM 2250 ZENEX
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of PM 1250 and PM 2250 ZENEX 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-0036-2018 |
| 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
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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: 4471223 4435620 4471226 4478259 4473923 4465800 4465795 2960123 4471236 4465866 2960119 448…Serial Numbers: 4471223 4435620 4471226 4478259 4473923 4465800 4465795 2960123 4471236 4465866 2960119 4480805 4456626 4456605 4456614 4456609 4455665 4470374 2992215 4470251 4478226 2992206 4435532 4436165 4442557 2888746 2992230 4470249 2992219 4481080 4477111 4486603 2992337 4478246 3028382 4470221 2992336 4470256 4470255 4477145 4477154 2992244 4479101 4470215 2817358 2897784 2897779 2897791 2878499 2912102 2912129 2912137 2912163 4427305 2992294 2992270 2992271 2870627 2888748 2912140 2912167 2912110 2912100 4419728 4428451 4495360 4428446 2992205 4479087 4485695 4486629 4486616 4486619 4486415 2992291 2992304 2992208 3028378 2992262 2836144 2992265 2992233 2992331 2992298 2992316 2992225 2992322 2992338 2992221 4480798 2992275 4583284 4507998 4505995 4508010 4540176 4495349 4501470 4510860 4508966 4495359 4535417 4507981 4427067 4508009 4552833 4501456 4505305 4505336 45 |
|---|
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-0036-2018%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.