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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Maquet Cardiovascular, LLC: Acrobat-i Vacuum Positioners Recalled Due to Arm Locking Failure

Agency Publication Date: December 19, 2023
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Summary

Maquet Cardiovascular is recalling approximately 6,472 Acrobat-i Vacuum Positioner Systems (Model XP-5000Z) because the positioner arm may fail to tighten or lock correctly during use. This medical device is used during surgical procedures to stabilize and position the heart; a failure to lock can lead to unintended movement during a critical operation. These units were distributed nationwide in the United States and globally. If you have this device, please contact the manufacturer or your healthcare administrator immediately to ensure the device is functioning correctly or to arrange for further instructions.

Risk

If the positioner arm fails to lock or suddenly loosens during surgery, the heart may shift unexpectedly. This instability can cause surgical complications, tissue damage, or delays in the procedure while the medical team attempts to stabilize the device or replace it.

What You Should Do

  1. Identify your device by checking for Model Number XP-5000Z and UDI-DI 00607567500006 on the product labeling or packaging.
  2. Verify if your device is part of the affected batch by checking for the following lot numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214053, 3000214054, 3000214255, 3000221064, 3000214052, 3000225770, 3000226531, 3000225866, 3000225769, 3000231209, or 3000231210.
  3. If you are a healthcare provider, immediately inspect your inventory for the affected lot numbers and contact the manufacturer, Maquet Cardiovascular, LLC, for specific guidance regarding these units.
  4. Patients who have recently undergone surgery involving a vacuum positioner and have concerns should contact their healthcare provider for further information.
  5. Contact Maquet Cardiovascular at their New Jersey headquarters or through your local distributor for further instructions and potential product resolution.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer guidance and potential resolution

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

Affected Products

Product: Acrobat-i Vacuum Positioner System
Model / REF:
XP-5000Z
UPC Codes:
00607567500006
Lot Numbers:
3000195267
3000195268
3000195273
3000195663
3000199248
3000199725
3000204637
3000207240
3000211594
3000212053
3000213219
3000214053
3000214054
3000214255
3000221064
3000214052
3000225770
3000226531
3000225866
3000225769
3000231209
3000231210

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93477
Status: Active
Manufacturer: Maquet Cardiovascular, LLC
Sold By: hospital distributors; Maquet Cardiovascular LLC
Manufactured In: United States
Units Affected: 6472 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 ยท 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.