BIOTRONIK, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2376-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 30, 2015

Date Posted: August 19, 2015

Recall Number: Z-2376-2015

Event ID: 71658

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.

Status: Terminated

Product Quantity: 768 units (software)

Code Information:

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

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated