CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report
Acrobat SUV Vacuum Stabilizer System, ST recalled
Maquet Cardiovascular is recalling Acrobat SUV Vacuum Stabilizer System, ST, distributed nationwide in the US. The recall was initiated on 16 Oct 2024 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-0485-2025
- FDA event ID
- 95614
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Oct 2024
- FDA classified
- 18 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Oct 2024 | Recall initiated by company | |
| 18 Nov 2024 | Classified by FDA | +33 days |
| 27 Nov 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Where it was distributed
Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.
Questions about this recall
Why was it recalled?
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
Which lots are affected?
Model Number C-OM-9000Z. UDI-DI Number: 00607567900004. Batch Numbers: 3000270477, 3000274130, 3000279333, 3000325028, 3000349295, 3000356305, 3000368568, 3000288446, 3000314841, 3000318197, 3000340989, 3000315179, 3000284660, 3000279342, 3000325025, 3000340964, 3000274640, 3000280059, 3000280563, 3000325362, 3000284695, 3000314838, 3000349055, 3000356063, 3000298982, 3000317739, 3000376711, 3000279839, 3000399170, 3000362853, 3000337154, 3000321412, 3000299814, 3000288445, 3000269996.
Where was it sold?
Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.
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.
Other products in this recall event
2 other products · FDA event 95614This product is part of a recall event; the main page for the event is Acrobat-i Vacuum Stabilizer System recalled by Maquet Cardiovascular.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acrobat-i Vacuum Stabilizer System recalled by Maquet Cardiovascular | Maquet Cardiovascular | Sterility | Nationwide | |
| CLASS II | Acrobat-i Positioner recalled by Maquet Cardiovascular | Maquet Cardiovascular | Sterility | Nationwide |
More recalls from Maquet Cardiovascular
All 252| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Sterility | Nationwide |
| Device | CLASS II | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System recalled | Maquet Cardiovascular | Device Malfunction | Nationwide |
| 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 |
| Device | CLASS II | Heartstring III Proximal Seal System recalled by Maquet Cardiovascular | Maquet Cardiovascular | Packaging Defects | Nationwide |
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| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |