Data Foundry

Medical device recalls 2019

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower… — Class II medical device recall Z-0983-2019

Terminated recall by Maquet Cardiovascular, LLC, reported 2019-03-13, distributed nationwide. Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary art

Recall numberZ-0983-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMaquet Cardiovascular, LLC, Wayne, NJ, United States
Recall initiated2019-01-24
Classified2019-03-07
Reported by FDA2019-03-13
Terminated2020-07-13
DistributedNationwide (US)
Countries outside the USAU, BE, CA, CH, CZ, DE, ES, FR, GB, KR, NL, RU
UPC / GTIN / UDI-DI20607567700745
Lot numbers96255605, 96255607, 96255608, 96255609, 96255611
Model numbersCB-1000

Product

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).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0983-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.