Maquet Cardiovascular, LLC: Acrobat-i Vacuum Stabilizer System Recalled for Risk of Device Breakage

Agency Publication Date: October 22, 2023

Summary

Maquet Cardiovascular, LLC is recalling 2,951 units of the Maquet Acrobat-i Vacuum Stabilizer System, a device used to stabilize the heart during cardiac surgical procedures. The recall was initiated because the Housing Mount Jaw of the device can break during normal use, which could lead to serious medical complications or procedural delays. This device is specifically used during surgeries that require a sternotomy incision approach.

Risk

If the Housing Mount Jaw breaks during surgery, it can cause direct injury to the heart tissue, blood vessels, coronary arteries, or existing bypass grafts. Additionally, a breakage could force surgeons to delay the procedure or change their surgical approach unexpectedly to manage the equipment failure.

What You Should Do

Identify if your facility has the Maquet Acrobat-i Vacuum Stabilizer System (Product Code OM-10000Z) by checking the UDI-DI 00607567100008 on the packaging.
Check the device's lot numbers against the following affected list: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, and 3000204442.
If you have an affected device, contact Maquet Cardiovascular, LLC at their Wayne, New Jersey headquarters or your local representative for specific instructions regarding the return or replacement of these units.
Patients who have recently undergone cardiac surgery where this device may have been used should contact their healthcare provider if they have concerns about their recovery or procedure.
Healthcare providers can contact the FDA for more information at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer contact and medical consultation

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

Affected Products

Product: Maquet Acrobat-i Vacuum Stabilizer System

Model / REF:

OM-10000Z

UPC Codes:

00607567100008

Lot Numbers:

3000188485

3000193165

3000193670

3000195673

3000198652

3000199944

3000201253

3000204442

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93085

Status: Active

Manufacturer: Maquet Cardiovascular, LLC

Sold By: Authorized medical distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 2951 units

Distributed To: Nationwide

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

Risk

What You Should Do

Identify if your facility has the Maquet Acrobat-i Vacuum Stabilizer System (Product Code OM-10000Z) by checking the UDI-DI 00607567100008 on the packaging.

Check the device's lot numbers against the following affected list: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, and 3000204442.

If you have an affected device, contact Maquet Cardiovascular, LLC at their Wayne, New Jersey headquarters or your local representative for specific instructions regarding the return or replacement of these units.

Patients who have recently undergone cardiac surgery where this device may have been used should contact their healthcare provider if they have concerns about their recovery or procedure.

Healthcare providers can contact the FDA for more information at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.