Abbott Medical: Aveir Leadless Pacemaker Recalled Due to Potential Mode Change Interference

Agency Publication Date: April 29, 2024

Summary

Abbott Medical is recalling approximately 10,610 Aveir Leadless Pacemakers (model REF: LSP112V) because electromagnetic interference can cause the device to unexpectedly change its operating mode. This defect can lead to inappropriate pacing or a lack of necessary heart stimulation for the patient. Consumers with these implanted devices should consult their healthcare provider to discuss the risks and potential management of the device.

Risk

Electromagnetic interference can disrupt the pacemaker's internal sensors, causing it to switch modes. This switch may result in heart palpitations, dizziness, fainting, or the return of pre-implantation symptoms due to inadequate heart rhythm support.

What You Should Do

Confirm if your device is affected by checking the model REF: LSP112V and your specific serial number against the list of 10,610 affected units (e.g., serial numbers 524933, 1301967, 1304509, and others).
Contact your cardiologist or healthcare provider immediately to discuss this recall and determine if a device check or reprogramming is necessary.
Monitor for any new or worsening symptoms such as heart palpitations, dizziness, lightheadedness, or fainting, and report them to your physician right away.
Follow any specific guidance provided in the Abbott Medical notification letter regarding environmental sources of electromagnetic interference that should be avoided.
Contact Abbott Medical for further information or to ask specific technical questions regarding your implanted device.
For additional questions or to report an incident, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Medical consultation and potential monitoring.

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

Affected Products

Product: Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

Model / REF:

REF: LSP112V

UPC Codes:

05415067034472

Lot Numbers:

524933

524932

1301967

1301958

1301969

1301971

1301953

1301965

1301952

1301966

1301916

1301963

1301912

1301968

524931

1304777

1301964

1304509

1304507

1302859

1304519

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94072

Status: Active

Manufacturer: Abbott Medical

Sold By: Hospitals; Medical Centers; Surgical Centers

Manufactured In: United States

Units Affected: 10,610 units

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

Confirm if your device is affected by checking the model REF: LSP112V and your specific serial number against the list of 10,610 affected units (e.g., serial numbers 524933, 1301967, 1304509, and others).

Contact your cardiologist or healthcare provider immediately to discuss this recall and determine if a device check or reprogramming is necessary.

Monitor for any new or worsening symptoms such as heart palpitations, dizziness, lightheadedness, or fainting, and report them to your physician right away.

Follow any specific guidance provided in the Abbott Medical notification letter regarding environmental sources of electromagnetic interference that should be avoided.

Contact Abbott Medical for further information or to ask specific technical questions regarding your implanted device.

For additional questions or to report an incident, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).