ModerateClass IIOngoing

FDA Devices recall · Reported August 9, 2023

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2272-2023.

Q: Where was the recalled product distributed?

Distribution: 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..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 posit…

Recall #: Z-2272-2023
Affected scope: 401 units
Initiated: June 28, 2023

Compiled from official public sources by the publisher. · Updated September 2026

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Maquet Cardiovascular, LLC recalled ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabili… - a moderate-severity action.

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabili… was recalled by Maquet Cardiovascular, LLC in August 9, 2023. Reason: The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabi…. Check the official notice for the remedy. Verify recall #Z-2272-2023 with the FDA Devices before acting.

The recall

Maquet Cardiovascular, LLC issued this moderate-severity FDA Devices recall-The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabi….

Moderate
severity level: 401 units
affected scope: Class II
classification: August 9, 2023
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2272-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-2272-2023
Date reported	August 9, 2023
Date initiated	June 28, 2023
Recalling firm	Maquet Cardiovascular, LLC
Firm location	Wayne, NJ
Affected scope	401 units
Distribution	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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

401 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2272-2023) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.. Recalled by Maquet Cardiovascular, LLC. Units affected: 401 units.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2272-2023.

Where was the recalled product distributed? ▼

Distribution: 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..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported August 9, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026