Z-1233-2015Class II

ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr

Name: Z-1233-2015 ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr
Creator: Arrow International Inc
Published: 2015-02-05
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2015-02-05 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon... on 2015-02-05. FDA classified it as Class II and gives the reason as "Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1233-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Posted: 2015-03-02
Terminated: 2016-10-26
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Arrow International notified Users, Distributors, Risk Managers by letter dated February 5, 2015. The letter explains the labeling error and requests immediately discontinue use and quarantine product. Customers were instructed to complete the Recall Acknowledgement Form and return by fax to 1-855-419-8507 whether they have or do not have the affected product. Customers with questions were instructed to contact their local sales representataive or Customers Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Quantity in commerce: 165 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Belgium
Product codes and lots: Lot Number: 18F14M0001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

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)