Official recall record
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operate
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-11-21
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05414734509725
- Brand on record
- Abbott Medical
What the authority reported
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2022-06-17 · US FDA — Medical Devices
Merlin PCS 3650 programmer Model 3330 software - 2018-04-13 · US FDA — Medical Devices
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. - 2026-05-12 · US FDA — Medical Devices
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Other recalls from this brand
- 2025-10-06 · US FDA — Medical Devices
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 - 2025-10-06 · US FDA — Medical Devices
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
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