Arrow International FiberOptix Intra-Aortic Balloon… recallZ-1064-2013 · Arrow International Inc · initiated Nov 27, 2012
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
FDA root cause category: Process control
What the company is doing
Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.
Recall details
- Recall number
- Z-1064-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 27, 2012
- Posted by the FDA
- Apr 6, 2013
- Recalling firm
- Arrow International Inc
- Quantity
- 188 units
- Product code
- DSP
- FDA submissions
- K000729, K021462
- Distribution
- Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
Product description
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Code information (models, lots, serial numbers)
Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921
Other devices under the same FDA submission
13 devices cleared under K000729, K021462 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN000260Teleflex Incorporated · System, balloon, intra-aortic and control4 deaths698 reports
- ARROW IPN000257Teleflex Incorporated · System, balloon, intra-aortic and control3 deaths233 reports
- ARROW IPN915322Teleflex Incorporated · System, balloon, intra-aortic and control1 recall29 reports
- ARROW IPN039793Teleflex Incorporated · System, balloon, intra-aortic and control62 reports
- ARROW IPN915321Teleflex Incorporated · System, balloon, intra-aortic and control1 recall7 reports
- ARROW IPN915320Teleflex Incorporated · System, balloon, intra-aortic and control1 recall0 reports
- ARROW IPN000255Teleflex Incorporated · System, balloon, intra-aortic and control32 reports
- ARROW IPN039788Teleflex Incorporated · System, balloon, intra-aortic and control29 reports
- ARROW IPN039782Teleflex Incorporated · System, balloon, intra-aortic and control23 reports
- ARROW IPN039778Teleflex Incorporated · System, balloon, intra-aortic and control16 reports
- ARROW IPN038075Teleflex Incorporated · System, balloon, intra-aortic and control12 reports
- ARROW IPN038074Teleflex Incorporated · System, balloon, intra-aortic and control7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 64527).
- Z-1065-2013 · TerminatedArrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation th…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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