Z-1055-2016Class I

FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy...

Name: Z-1055-2016 FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy...
Creator: Arrow International, Inc., Division of Teleflex Medical Inc.
Published: 2016-02-10
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2016-02-10 / Terminated / root cause: manufacturing process

FDA source

Arrow International, Inc., Division of Teleflex Medical Inc. began a recall of FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during... on 2016-02-10. FDA classified it as Class I and gives the reason as "The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device". 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-1055-2016
Classification: Class I
Status: Terminated
Initiated: 2016-02-10
Posted: 2016-03-11
Terminated: 2021-05-12
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon counterpulsation 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: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 13,405 US and 33,735 OUS in total
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
Product codes and lots: Batch: 18F14A0031 18F14A0032 18F14A0033 18F14D0066 18F14E0018 18F14E0072 18F14F0067 18F14F0079 18F14G0045 18F14G0046 18F14G0081 18F14H0037 18F14J0023 18F14L0014 18F14M0033 18F15A0010 18F15B0015 18F15C0004 18F15C0023 18F15D0025 18F15D0052 18F15E0020 18F15F0002 18F15F0039 18F15G0005 18F15G0015 18F15H0006 18F15H0037 18F15H0051 18F15J0026 18F15L0007 18S14G0046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1055-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1055-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1056-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1057-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1058-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1059-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1060-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1061-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1062-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10
Z-1063-2016	Class I	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-10

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)