FDA Devices recall · Reported March 11, 2015
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Arrow International Inc recalled ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840… - a moderate-severity action.
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840… was recalled by Arrow International Inc in March 11, 2015. Reason: Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the…. Check the official notice for the remedy. Verify recall #Z-1233-2015 with the FDA Devices before acting.
The recall
Arrow International Inc issued this moderate-severity FDA Devices recall-Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the….
- Moderate
- severity level
- 165 units
- affected scope
- Class II
- classification
- March 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1233-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1233-2015) was formally reported on March 11, 2015, with the manufacturer initiating the action on February 5, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Arrow International Inc is listed as the recalling firm, operating out of Reading, PA. Federal records list the affected scope as 165 units.
The documented reason for this recall is: Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Belgium. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Reason for recall
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1233-2015 |
| Date reported | March 11, 2015 |
| Date initiated | February 5, 2015 |
| Recalling firm | Arrow International Inc |
| Firm location | Reading, PA |
| Affected scope | 165 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Belgium |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1233-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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