Z-2376-2015Class II

PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software...

Name: Z-2376-2015 PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software...
Creator: BIOTRONIK, Inc.
Published: 2015-06-30
License: https://open.fda.gov/license/

BIOTRONIK AG / initiated 2015-06-30 / Terminated / root cause: software

FDA source

BIOTRONIK, Inc. began a recall of 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... on 2015-06-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2376-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-30
Posted: 2015-08-13
Terminated: 2015-12-24
Recalling firm: BIOTRONIK AG
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.
Product code: rce
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: BIOTRONIK sent the Important Product Information letter and the Acknowledgement of Important Product Information Form, dated June 20, 2015, to affected physicians with the following recommendations: -Review programming settings for your patients with CRT-P or CRT-D devices. -If you have a patient with a device programmed to Ventricular pacing: LV, arrange to have the patients device reprogrammed to an appropriate approved mode (i.e. "Ventricular pacing: RV" or "Ventricular pacing: BiV"). -Physicians are requested to sign the Acknowledgement of Important Product Information Form and immediately fax to 800-913-6993 or email to [email protected]. BIOTRONIK'S representative will update your programmer with approved 1502.U programmer software. Following this update, the Ventricular pacing: LV feature will no longer be available. However, a device previously programmed with "Ventricular pacing: LV will remain programmed in this mode unless and until the pacing mode setting is changed. If you have any questions concerning this Important Product Information, please contact the BIOTRONIK Technical Services Department: Telephone: 1-(800) 284-6689 (24-hour service)
Quantity in commerce: 768 units (software)
Distribution: Nationwide Distribution.
Product codes and lots: Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2376-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2376-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-13

Product code rce

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)