Z-1065-2013Class II

Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number...

Name: Z-1065-2013 Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number...
Creator: Arrow International Inc
Published: 2012-11-27
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2012-11-27 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of 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... on 2012-11-27. FDA classified it as Class II and gives the reason as "Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1065-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-27
Posted: 2013-04-06
Terminated: 2015-06-02
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: 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 tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 637 units
Distribution: Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
Product codes and lots: Lot Numbers: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1065-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1064-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-05
Z-1065-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-05

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)