Arrow International Recalls FiberOptix Intra-Aortic Balloon Catheter Kits
Arrow International is recalling 188 units of FiberOptix Intra-Aortic Balloon Catheter Kits due to a potential internal leak at the fill port.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a high-risk medical device with a defect that may necessitate removal and replacement, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Arrow International Inc is recalling 188 units of the FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc, Product Number IAB-05830-LWS. The affected lot numbers are KF2073734, KS2083999, KF2083869, and KF2083921. The product was distributed worldwide, including in the USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
The recall is due to 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 IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Healthcare providers and facilities should stop using the affected units and contact Arrow International Inc for instructions on removal and replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 188
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921
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.
See all 2 products in this recall →Related recalls
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Similar recalls
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