PSW 1203 — Class II medical device recall Z-2376-2015
Terminated recall by BIOTRONIK, Inc., reported 2015-08-19, distributed nationwide. Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled becau
| Recall number | Z-2376-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOTRONIK, Inc., Lake Oswego, OR, United States |
| Recall initiated | 2015-06-30 |
| Classified | 2015-08-13 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2015-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 768 units |
| Reason classes | software, unapproved product |
| Model numbers | 394229, 400335, 403222, 406797, 408849 |
Product
PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
Reason for recall
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
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-2376-2015. 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.