Reported Jun 17, 2026 · Ongoing

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

Abbott Medical

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Medical · 15900 Valley View Ct · Sylmar, CA · 91342-3577

Is this the product you have?

  • Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Lot codes and dates
  • Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
Amount recalled
11182 programs

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.