Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits
Arrow International is recalling 637 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used for counter-pulsation therapy where a defect may necessitate removal and replacement, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 637 units of the FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc, Product Number IAB-05840-LWS. The recall affects specific lot numbers: KF2073694, KF2083874, KF2083966, KF2094179, KF2073788, KF2083927, and KF2084059.
The recall is being conducted because of a potential internal leak at the fill port of the stainless steel tip. This defect may necessitate the removal and replacement of the catheter during use. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including in the USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa. Healthcare providers and facilities should check their inventory for the listed lot numbers and contact Arrow International for instructions on removal and replacement.
The recalled product
- Product
- Arrow 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 therapy.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 637
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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