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Acrobat-i Positioner recallZ-0589-2024 · Maquet Cardiovascular, LLC · initiated Oct 31, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The Positioner Arm may not tighten or lock during normal use.

FDA root cause category: Component design/selection

What the company is doing

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

Recall details

Recall number
Z-0589-2024
Status
Open, Classified
Initiated by the company
Oct 31, 2023
Posted by the FDA
Dec 19, 2023
Recalling firm
Maquet Cardiovascular, LLC
Quantity
6472 units
Product code
MWS
Distribution
US Nationwide. Global Distribution.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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