—#116404

Product

Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

FDA product code: DSP — System, Balloon, Intra-Aortic And Control
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K000729, K021462
Affected lot / code info: Lot Numbers: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059

Why it was recalled

Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

Root cause (FDA determination)

Process control

Action the firm took

Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.

Timeline

Recall initiated: 2012-11-27
Posted by FDA: 2013-04-06
Terminated: 2015-06-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116404. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.