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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Maquet Cardiovascular
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| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
| Device | CLASS II | Heartstring III Proximal Seal System Intravascular recalled | Maquet Cardiovascular | Packaging Defects | Nationwide |
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Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |