FiberOptix IAB Sheath, Ultra 8 Fr, 30cc recallZ-0792-2011 · Arrow International, Inc., Division of Teleflex Medical Inc. · initiated Oct 11, 2010
Terminated All recalls posted in December 2010
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., Division of Teleflex Medical 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
SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
FDA root cause category: Device Design
What the company is doing
Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
Recall details
- Recall number
- Z-0792-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 11, 2010
- Posted by the FDA
- Dec 23, 2010
- Recalling firm
- Arrow International, Inc., Division of Teleflex Medical Inc.
- Quantity
- 12, 261 units
- Product code
- DSP
- FDA submissions
- K000729, K021462
- Distribution
- Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.
Product description
FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Lot Numbers: KF0097980 KF0097981 KF0097982 KF0098037 KF0098079 KF0108149 KF0108194 KF0108242 KF0108294 MF0011388 MF0021613 MF0021614 MF0021615 MF0021616 MF0031841 MF0031842 MF0032167 MF0042396 MF0042783 MF0042784 MF0042785 MF0053022 MF0063352 MF0073779 MF0073902 MF0074070 MF7065674 MF7128561 MF8092999 MF8103156 MF8113922 MF8114009 MF8124160 MF8124308 MF8124409 MF9025252 MF9025253 MF9025254 MF9025255 MF9025320 MF9025322 MF9035383 MF9035385 MF9035611 MF9035612 MF9035835 MF9035954 MF9056741 MF9056846 MF9057067 MF9067348 MF9067349 MF9067737 MF9077887 MF9077970 MF9077972 MF9078195 MF9078196 MF9078197 MF9078198 MF9078200 MF9078344 MF9078345 MF9078346 MF9078347 MF9088679 MF9088680 MF9099229 MF9099230 MF9099231 MF9099232 MF9099233 MF9099310 MF9099353 MF9100006 MF9100007 MF9109757 MF9109758 MF9110055 MF9110192 MF9110303 MF9110304 MF9110305 MS9056709 MS9056810 MS9056811 MS9109705 MS9109708
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 56965).
- Z-0790-2011 · TerminatedArrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
- Z-0791-2011 · TerminatedArrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
- Z-0793-2011 · TerminatedFiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
- Z-0969-2011 · TerminatedPercutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
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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