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Recall Observatory FDA recall evidence

Device 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.

Z-2376-2015

June 30, 2015

Class II

Product summary

Firm
BIOTRONIK, Inc.
Event
Event 71658
Status
Terminated
Classification
Class II
Quantity
768 units (software)
Official record key
device-enforcement:Z-2376-2015

Official wording

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.

Code information: Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.