Class II — BIOTRONIK, Inc.
| Recalling firm | BIOTRONIK, INC. |
|---|---|
| Registered facility | BIOTRONIK, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 768 units (software) |
| Distribution | Nationwide Distribution. |
| Initiated | 2015-06-30 |
| Classified | 2015-08-13 |
| Terminated | 2015-12-24 |
| Recall number | Z-2376-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BIOTRONIK, Inc. (Z-2376-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71658/
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