AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Reported: March 13, 2019 Initiated: January 24, 2019 #Z-0983-2019
Product Description
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Reason for Recall
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- 7,880 each (1,576 packs of 5)
- Distribution
- Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility. Recalled by Maquet Cardiovascular, LLC. Units affected: 7,880 each (1,576 packs of 5).
Why was this product recalled? ▼
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2019. Severity: Moderate. Recall number: Z-0983-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11