Merlin PCS 3650 Programmer with Model 3330 Software Version 23 — Class II medical device recall Z-0032-2018
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-0032-2018 |
|---|---|
| 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 | 10,453 units |
| Reason classes | software |
| Model numbers | 3330, 3650 |
Product
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
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-0032-2018. 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.