FDA Device recall Z-1495-2022
Merlin PCS 3650 programmer Model 3330 software
- FDA Device
- Class II
- ongoing
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class II recall of Merlin PCS 3650 programmer Model 3330 software by St Jude Medical Cardiac Rhythm Management Division, citing there is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1495-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-17 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Merlin PCS 3650 programmer Model 3330 software
Reason
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Identifiers
| code_info | Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725 |
|---|
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-1495-2022%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.