Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

FDA Recall Z-1259-2015 · Posted 2015-03-10

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDSP
Date Initiated2013-11-08
Date Terminated2015-03-16
Product Quantity166 units

Reason for Recall

Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

Firm Action

Arrow International Inc notified accounts by letter dated 11/8/13 describing the problem and requested users to immediately discontinue use and return product. A Recall Acknowledgement form was to be completed and returned.

Root Cause

Process control

Distribution Pattern

Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021462ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840Arrow Intl., Inc. · 2002-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑