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Use caution Medical device recall · FDA · Published June 28, 2023

Maquet ACROBAT SUV Vacuum System Recall: Stabilization Risk

Maquet recalls ACROBAT SUV Vacuum Off-Pump System (part C-OM-90:000S) due to potential instability during cardiac surgery, risking device failure and patient safety.

🇺🇸 FDA recall #Z-2272-2023Medical deviceMaquet ›
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Contact the company

Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094
✎ GovInfoNow plain-language explainer

Maquet is recalling a specific vacuum system used in cardiac surgery because its blade might not stay securely attached to the device. This could lead to the system failing during surgery, potentially causing harm to the patient. Read more at govinfonow.com/recall/57785-maquet-acrobat-suv-vacuum-system-recall-stabilization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57785-maquet-acrobat-suv-vacuum-system-recall-stabilization-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2272-2023

Cite this page

“Maquet ACROBAT SUV Vacuum System Recall: Stabilization Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57785-maquet-acrobat-suv-vacuum-system-recall-stabilization-risk. Based on FDA recall #Z-2272-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2272-2023%22&limit=1).

Maquet Cardiovascular, LLC recalled the ACROBAT SUV Vacuum Off-Pump System (Part Number C-OM-9000S) on June 28, 2023, according to the FDA. The Standard Blade may not securely latch onto the Activator Drive, posing a risk of device component release into patients or procedural delays.

How to tell if you have it

  • Brand: Maquet
  • Product: ACROBAT SUV Vacuum Off-Pump System
  • Part Number: C-OM-9000S
  • UDI-DI: 00607567700543
  • Quantity: 401 units

The hazard

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.

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since 2019-01-24. Other recent recalls include the Maquet Vasoview Hemopro 2 (2026-06-02), Maquet Heartstring III Proximal Seal System (2025-08-15), and Maquet Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (2025-08-06). Additional recent recalls involve the Maquet Flow-i Anesthesia Machines (2026-06-24), Maquet PowerLED 300 Concealed Lighting System (2026-08-07), and Intuitive Surgical Da Vinci Surgical System (2026-04-22).

How to tell if you have this one

Check for the part number C-OM-9000S on the ACROBAT SUV Vacuum Off-Pump System used in cardiac and chest surgery. The device has a unique identifier (UDI-DI: 00607567700543).

  • Brand
    Maquet
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • 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.
Recall numberProduct, codes & lotsQuantity
Z-2271-2023ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.; UDI-DI: 00607567700215785 units
Z-2272-2023ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.; UDI-DI: 00607567700543401 units
Z-2273-2023ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.; UDI-DI: 00607567700536594 units
Z-2274-2023ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.; UDI-DI: 00607567700581334 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Verify if the blade securely latches onto the activator drive before use.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Jun 28, 202312. FDA classified it Class II: Jul 31, 202323. Published in FDA’s Enforcement Report: Aug 9, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The device may not be safe to use as it could fail during surgery, risking patient safety. The manufacturer recommends checking the blade's secure attachment.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2272-2023 (June 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2272-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA