Z-1259-2015Class II

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

Name: Z-1259-2015 Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Creator: Arrow International Inc
Published: 2013-11-08
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2013-11-08 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS on 2013-11-08. FDA classified it as Class II and gives the reason as "Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere". 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-1259-2015
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2015-03-10
Terminated: 2015-03-16
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 166 units
Distribution: Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
Product codes and lots: Lot Number: KF1111796 Exp. Date: 11/30/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1259-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1259-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-10

Product code DSP

K021462Class IIArrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,iab5840Arrow Intl., Inc. / cleared 2002-06-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)