Abbott Medical: Merlin PCS 3650 Programmer Recalled Due to Pacemaker Finalization Failure

Agency Publication Date: December 23, 2024

Summary

Abbott Medical has recalled approximately 7,295 Merlin PCS 3650 programmers and Model 3330 software systems used with leadless pacemakers. A software anomaly can cause the setup process to fail if a specific sequence of actions occurs during a brief loss of connection. If this failure happens, the pacemaker may stop providing necessary pacing to the patient. Healthcare providers and patients should contact their medical professional or Abbott Medical for further guidance on device management.

Risk

The defect can prevent a leadless pacemaker from being properly finalized, leading to a complete lack of heart pacing for the patient. This failure to pace poses a significant risk to patients who rely on the device to maintain a life-sustaining heart rhythm.

What You Should Do

Identify if your device is affected by checking for Programmer Model Number 3650 or MER3700 (OUS) with UDI-DI code 05414734509725.
Verify if your system is running affected Software Version Numbers including 28.0.1 (REV 2 or 3), 28.1.1 (REV 1), 28.1.2 (REV 1), or 28.1.4 (REV 1).
Check your device serial number against the recalled list, which includes thousands of units such as 12995, 16103, 30831, 12040778, and many others listed in the official notice.
Be alert for a 'loss of telemetry detected' window displayed on the programmer during the finalization step of a leadless pacemaker system, as this indicates pacing may have stopped.
Healthcare providers should contact Abbott Medical directly to discuss necessary software updates or clinical procedure adjustments.
Patients with leadless pacemakers who are concerned about their device setup should contact their healthcare provider or cardiologist immediately.
For additional questions or support, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Merlin PCS 3650 Programmer (Model 3330 Software)

Model / REF:

3650

3330

UPC Codes:

05414734509725

Lot Numbers:

05414734509725

28.0.1 REV 2

28.0.1 REV 3

28.1.1 REV 1

28.1.2 REV 1

28.1.4 REV 1

Product: Merlin PCS MER3700 Programmer (OUS)

Model / REF:

MER3700

UPC Codes:

05414734509725

Lot Numbers:

05414734509725

28.1.2 REV 1 13000664

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95813

Status: Active

Manufacturer: Abbott Medical

Sold By: Abbott Medical authorized distributors; Direct medical sales

Manufactured In: United States

Units Affected: 7295 programmers

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your device is affected by checking for Programmer Model Number 3650 or MER3700 (OUS) with UDI-DI code 05414734509725.

Verify if your system is running affected Software Version Numbers including 28.0.1 (REV 2 or 3), 28.1.1 (REV 1), 28.1.2 (REV 1), or 28.1.4 (REV 1).

Check your device serial number against the recalled list, which includes thousands of units such as 12995, 16103, 30831, 12040778, and many others listed in the official notice.

Be alert for a 'loss of telemetry detected' window displayed on the programmer during the finalization step of a leadless pacemaker system, as this indicates pacing may have stopped.

Healthcare providers should contact Abbott Medical directly to discuss necessary software updates or clinical procedure adjustments.

Patients with leadless pacemakers who are concerned about their device setup should contact their healthcare provider or cardiologist immediately.

For additional questions or support, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Merlin PCS 3650 Programmer (Model 3330 Software)

Model / REF:

3650

3330

UPC Codes:

05414734509725

Lot Numbers:

05414734509725

28.0.1 REV 2

28.0.1 REV 3

28.1.1 REV 1

28.1.2 REV 1

28.1.4 REV 1

Product: Merlin PCS MER3700 Programmer (OUS)

Model / REF:

MER3700

UPC Codes:

05414734509725

Lot Numbers:

05414734509725

28.1.2 REV 1 13000664

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95813

Status: Active

Manufacturer: Abbott Medical

Sold By: Abbott Medical authorized distributors; Direct medical sales

Manufactured In: United States

Units Affected: 7295 programmers