medical MODERATE Updated 2026-06-17

Abbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650

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Recalled Product

Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

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Hazard / Issue

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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