Class II U.S. Food and Drug Administration

Abbott Medical Merlin" Patient Care System software Merlin" PCS 3650 programmer Model recall: Software malfunction may occur during pacing capture threshold test

Recall published 4 months ago

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

The hazard: Device malfunction

The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

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

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2405-2026
Published
June 17, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abbott Medical
Product type
Medical devices
Units affected
11182 programs
Distribution
Nationwide
Made in
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)
UPC codes
05414734509725

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05414734509725

Model or item number

On the rating label, the box or the instruction sheet.

  • 3330

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Abbott Medical — The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  3. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  4. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Abbott Medical — 15900 Valley View Ct, Sylmar, CA, 91342-3577

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott Medical medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05414734509725; model number 3330. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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