Z-2274-2023Class II

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for...

Name: Z-2274-2023 ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for...
Creator: Maquet Cardiovascular, LLC
Published: 2023-06-28
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2023-06-28 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery on 2023-06-28. FDA classified it as Class II and gives the reason as "The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2274-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-28
Posted: 2023-07-31
Recalling firm: Maquet Cardiovascular LLC
Product: ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Product code: DWS Instruments, Surgical, Cardiovascular
Reason for recall: The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT MEDICAL DEVICE Removal notification dated 6/28/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have received the ACCESSRAIL Platform (Standard Blade), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer System having one or more of the lot numbers that are affected by this recall. " Please examine your inventory immediately to determine if you have any of the ACCESSRAIL Platform (Standard Blades), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer System with the product codes/lot numbers listed in this notice. " If you have unused/unexpired affected product that you will be returning from your inventory, please contact Maquet/Getinge Customer Service at 888- 9GETUSA (888-943 8872) (option 2) between the hours of 8 AM and 6 PM Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. o If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. o No new product is expected to exhibit this issue. " Please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (pages 5 & 6) to acknowledge that you have received this notification. " Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to +1(877) 589-3171. " Please forward this information to all current and potential ACCESSRAIL Platform (Standard Blades), ACCESSRAIL Platform (Deep Blades), ACROBAT SUV Vacuum Off-Pump System, ACROBAT V Vacuum Off-Pump System, or ACROBAT-i Vacuum Stabilizer 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 actio
Quantity in commerce: 334 units
Distribution: Worldwide distribution - US Nationwide and the countries of Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and United Arab Emirates.
Product codes and lots: UDI-DI: 00607567700581

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2274-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2271-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31
Z-2272-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31
Z-2273-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31
Z-2274-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-31

Product code DWS

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)