CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report
Merlin PCS programmer recalled by St Jude Medical
St Jude Medical is recalling Merlin PCS programmer (, distributed nationwide in the US. The recall was initiated on 16 Apr 2018 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-2329-2018
- FDA event ID
- 80212
- Recalling firm
- St Jude Medical, Sylmar, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2018
- FDA classified
- 28 Jun 2018
- Reported
- 4 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 16 Apr 2018 | Recall initiated by company | |
| 28 Jun 2018 | Classified by FDA | +73 days |
| 4 Jul 2018 | 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
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Where it was distributed
U.S. Nationwide distribution
Questions about this recall
Why was it recalled?
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Which lots are affected?
Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)
Where was it sold?
U.S. 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from St Jude Medical
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|---|---|---|---|---|---|
| Device | CLASS II | CardioMEMS Heart Failure (HF) System that consist recalled | St. Jude Medical | Device Malfunction | Nationwide |
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| Device | CLASS II | Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled | St. Jude Medical | Labeling Errors | Nationwide |
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