PM1214 NUANCE SR RF — Class II medical device recall Z-0034-2018
Terminated recall by St Jude Medical Inc., reported 2017-10-25. New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers tha
| Recall number | Z-0034-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc., Sylmar, CA, United States |
| Recall initiated | 2017-08-28 |
| Classified | 2017-10-19 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2020-07-08 |
| Quantity | 2,741 units |
| Reason classes | software |
| Serial numbers | 2276860, 2276862, 2613916, 2613917, 2613918, 2613919, 2613920, 2613921, 2613922, 2613923, 2613924, 2613925, 2613926, 2613927, 2613928, 2613929, 2613930, 2613931, 2613932, 2613933, 2613934, 2613935, 2613936, 2613937, 2613938 and 475 more |
Product
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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 for recall
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0034-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.