CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
Acrobat-i Vacuum Stabilizer System recalled by Maquet Cardiovascular
Maquet Cardiovascular is recalling Acrobat-i Vacuum Stabilizer System, distributed nationwide in the US. The recall was initiated on 28 Jun 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-2274-2023
- FDA event ID
- 92446
- Recalling firm
- Maquet Cardiovascular, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Jun 2023
- FDA classified
- 31 Jul 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Jun 2023 | Recall initiated by company | |
| 31 Jul 2023 | Classified by FDA | +33 days |
| 9 Aug 2023 | 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
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.
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
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00607567700581
Where was it sold?
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.
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
3 other products · FDA event 92446This product is part of a recall event; the main page for the event is Acrobat SUV Vacuum Off-Pump System recalled by Maquet Cardiovascular.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acrobat SUV Vacuum Off-Pump System recalled by Maquet Cardiovascular | Maquet Cardiovascular | Device Malfunction | Nationwide | |
| CLASS II | Accessrail Platform (Standard Blade) recalled by Maquet Cardiovascular | Maquet Cardiovascular | Device Malfunction | Nationwide | |
| CLASS II | Acrobat V Vacuum Off-Pump System recalled by Maquet Cardiovascular | Maquet Cardiovascular | Device Malfunction | 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 | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| 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 |