CLASS II Device recall · Reported 19 Aug 2015 · FDA Enforcement Report
PSW 1203.U/1, and PSW 1501.U Pacemaker Programmer recalled by Biotronik
Biotronik is recalling PSW 1203.U/1, and PSW 1501.U Pacemaker Programmer, distributed nationwide in the US. The recall was initiated on 30 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2376-2015
- FDA event ID
- 71658
- Recalling firm
- Biotronik, Lake Oswego, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2015
- FDA classified
- 13 Aug 2015
- Reported
- 19 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Device type
- Pacemakers & Defibrillators
Timeline
| 30 Jun 2015 | Recall initiated by company | |
| 13 Aug 2015 | Classified by FDA | +44 days |
| 19 Aug 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is PSW 1203.U/1, and PSW 1501.U Pacemaker Programmer recalled?
Yes. Biotronik recalled PSW 1203.U/1, and PSW 1501.U Pacemaker Programmer on 30 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2376-2015.
Why was it recalled?
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.
Which lots are affected?
Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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