Z-1057-2016Class I

FiberOptix Ultra 8 IAB: 8Fr 40cc

Name: Z-1057-2016 FiberOptix Ultra 8 IAB: 8Fr 40cc
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 40cc; Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby... 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-1057-2016
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 40cc; Product Code: IAB-05840-LWS 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: 18F14A0025 18F14A0026 18F14A0030 18F14A0049 18F14A0050 18F14A0051 18F14A0054 18F14A0057 18F14A0066 18F14A0067 18F14D0045 18F14E0004 18F14E0006 18F14E0016 18F14E0017 18F14E0052 18F14F0017 18F14F0047 18F14F0049 18F14F0080 18F14G0003 18F14G0004 18F14G0021 18F14G0037 18F14G0055 18F14G0056 18F14G0068 18F14G0070 18F14G0071 18F14G0076 18F14H0009 18F14H0030 18F14H0054 18F14H0055 18F14H0060 18F14H0061 18F14J0003 18F14J0005 18F14J0037 18F14K0006 18F14M0001 18F14M0014 18F14M0032 18F15A0005 18F15A0011 18F15A0026 18F15A0034 18F15B0005 18F15B0008 18F15B0010 18F15B0018 18F15B0020 18F15B0027 18F15C0002 18F15C0007 18F15C0010 18F15C0015 18F15C0024 18F15C0030 18F15C0036 18F15D0017 18F15D0032 18F15D0034 18F15D0043 18F15D0049 18F15E0003 18F15E0011 18F15E0014 18F15E0023 18F15E0029 18F15E0037 18F15F0011 18F15F0017 18F15F0021 18F15F0032 18F15G0001 18F15G0013 18F15G0021 18F15G0028 18F15G0034 18F15H0010 18F15H0015 18F15H0021 18F15H0024 18F15H0033 18F15J0013 18F15J0028 18F15J0038 18F15J0044 18F15J0049 18F15K0001 18F15K0007 18F15L0002 18S14G0068 18S14M0001 18S15C0002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1057-2016
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)