CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
Maquet Acrobat-i Vacuum Stabilizer System Intended recalled
Maquet Cardiovascular is recalling Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac, distributed nationwide in the US. The recall was initiated on 13 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0137-2024
- FDA event ID
- 93085
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Sep 2023
- FDA classified
- 22 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 13 Sep 2023 | Recall initiated by company | |
| 22 Oct 2023 | Classified by FDA | +39 days |
| 1 Nov 2023 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Where it was distributed
Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
Questions about this recall
Is Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac recalled?
Yes. Maquet Cardiovascular recalled Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac on 13 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0137-2024.
Why was it recalled?
Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.
Which lots are affected?
UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
Where was it sold?
Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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