Z-0589-2024Class II

Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

Name: Z-0589-2024 Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Creator: Maquet Cardiovascular, LLC
Published: 2023-10-31
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2023-10-31 / Open, Classified / root cause: design

FDA source

Maquet Cardiovascular, LLC began a recall of Acrobat-i Vacuum Positioner System, Model Number XP-5000Z on 2023-10-31. FDA classified it as Class II and gives the reason as "The Positioner Arm may not tighten or lock during normal use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0589-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-31
Posted: 2023-12-19
Recalling firm: Maquet Cardiovascular LLC
Product: Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Product code: MWS Stabilizer, Heart
Reason for recall: The Positioner Arm may not tighten or lock during normal use.
Root cause tag: design
FDA root cause: Component design/selection
Action: An URGENT MEDICAL DEVICE Removal notification letter dated 10/31/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have received the Acrobat-i Vacuum Positioner System having one or more of the lot numbers that are affected by this medical device removal. Please examine your inventory immediately to determine if you have any of the Acrobat-i Vacuum Positioner Systems with the product codes/lot numbers listed in this notice and remove these from use. Return any unused/unexpired affected product to Maquet/Getinge. Please contact Maquet/Getinge Customer Service at 888-880-2874 between the hours of 6 AM and 5 PM Pacific Standard Time to request a return authorization (RMA) number and shipping instructions. You will receive credit upon your acknowledgement that you have affected product for return. Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE REMOVAL - RESPONSE FORM (page 4 herein) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] (please note the email address is case sensitive) or by faxing the form to 1-800-859-8365. Please forward this information to all current and potential Acrobat-i Vacuum Positioner System users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Getinge: Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products. This voluntary removal only affects the products listed on page 1; no other products are affected by this voluntary medical device removal. If you have any questions, please contact your Maquet/Getinge representative or call the Maquet/Getinge Customer Support a
Quantity in commerce: 6472 units
Distribution: US Nationwide. Global Distribution.
Product codes and lots: UDI-DI: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0589-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0589-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-19

Product code MWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)