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Use caution Medical device recall · FDA · Published September 13, 2023

Maquet Acrobat-i Vacuum Stabilizer System Recall: Jaw Breakage Risk During Cardiac Surgery

Maquet recalls Acrobat-i Vacuum Stabilizer Systems with risk of housing mount jaw breaking during cardiac surgery, potentially causing injury to heart tissue or blood vessels. Affected units have specific product codes and lot numbers.

🇺🇸 FDA recall #Z-0137-2024Medical deviceMaquet ›
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Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094
✎ GovInfoNow plain-language explainer

Maquet is recalling its Acrobat-i Vacuum Stabilizer System used in cardiac surgery because the housing mount jaw can break during normal use. This breakage may injure heart tissue, blood vessels, or coronary arteries, or cause surgery delays. Read more at govinfonow.com/recall/57322-maquet-acrobat-i-vacuum-stabilizer-system-recall-jaw-breakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57322-maquet-acrobat-i-vacuum-stabilizer-system-recall-jaw-breakage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0137-2024

Cite this page

“Maquet Acrobat-i Vacuum Stabilizer System Recall: Jaw Breakage Risk During Cardiac Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57322-maquet-acrobat-i-vacuum-stabilizer-system-recall-jaw-breakage-risk. Based on FDA recall #Z-0137-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0137-2024%22&limit=1).

The FDA announced on September 13, 2023, that Maquet Cardiovascular, LLC is recalling the Maquet Acrobat-i Vacuum Stabilizer System due to a housing mount jaw breakage hazard. The agency issued recall number Z-0137-2024 for the Class II device intended for cardiac surgical procedures.

How to tell if you have it

  • Brand: Maquet
  • Product: Maquet Acrobat-i Vacuum Stabilizer System
  • Product Code: OM-10000Z
  • UDI-DI: 00607567100008
  • Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
  • Units affected: 2951

The hazard

According to the FDA, the housing mount jaw of these devices may break during normal use. This failure may result in injury to the epicardial tissue or vasculature, a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since January 24, 2019. Other recent recalls of similar products include Maquet Vasoview Hemopro 2 (June 2, 2026), Maquet Heartstring III Proximal Seal System (August 15, 2025), and Maquet Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (August 6, 2025). Other recent recalls of similar products include Acumed Hexalob Screw (May 28, 2026) and Merit Medical Custom Manifold Kit (December 4, 2025).

How to tell if you have this one

Check for product code OM-10000Z and lot numbers 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, or 3000204442 on the device. This system is intended for cardiac surgery through a sternotomy incision.

  • Brand
    Maquet
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Look for product code OM-10000Z and lot numbers listed above on the device.

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: “Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR” 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 49 days after the firm started it.

1. Firm started the recall: Sep 13, 202312. FDA classified it Class II: Oct 22, 202323. Published in FDA’s Enforcement Report: Nov 1, 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.

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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-0137-2024 (September 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0137-2024 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