CLASS II Device recall · Reported 17 Apr 2013 · FDA Enforcement Report
FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 30 cc recalled
Arrow International is recalling Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 30 cc. The recall was initiated on 27 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1064-2013
- FDA event ID
- 64527
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2012
- FDA classified
- 5 Apr 2013
- Reported
- 17 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 27 Nov 2012 | Recall initiated by company | |
| 5 Apr 2013 | Classified by FDA | +129 days |
| 17 Apr 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
Questions about this recall
Is FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 30 cc recalled?
Yes. Arrow International recalled FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 30 cc on 27 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-1064-2013.
Why was it 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.
Which lots are affected?
Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921
Where was it sold?
Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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