CLASS II Device recall · Reported 13 Mar 2019 · FDA Enforcement Report

Axius Blower Mister Product recalled by Maquet Cardiovascular

Maquet Cardiovascular is recalling Axius Blower Mister, distributed nationwide in the US. The recall was initiated on 24 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745

Quantity recalled7,880 each (1,576 packs of 5)

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-0983-2019
FDA event ID: 82090
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 24 Jan 2019
FDA classified: 7 Mar 2019
Reported: 13 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Jan 2019	Recall initiated by company
7 Mar 2019	Classified by FDA	+42 days
13 Mar 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

Product as listed by the FDA

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

Where it was distributed

Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

Which lots are affected?

Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745

Where was it sold?

Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and 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.

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