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.
FDA Recall Z-1057-2016 · Posted 2016-03-11
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Recall StatusTerminated
Product CodeDSP
Date Initiated2016-02-10
Date Terminated2021-05-12
Product Quantity13,405 US and 33,735 OUS in total
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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