FDA Devices recall · Reported April 25, 2018
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Datascope Corporation recalled Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon cat… - a moderate-severity action.
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon cat… was recalled by Datascope Corporation in April 25, 2018. Reason: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindicati…. Check the official notice for the remedy. Verify recall #Z-1385-2018 with the FDA Devices before acting.
The recall
Datascope Corporation issued this moderate-severity FDA Devices recall-The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindicati….
- Moderate
- severity level
- 13K units
- affected scope
- Class II
- classification
- April 25, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1385-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 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
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Reason for recall
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1385-2018 |
| Date reported | April 25, 2018 |
| Date initiated | February 21, 2018 |
| Recalling firm | Datascope Corporation |
| Firm location | Fairfield, NJ |
| Affected scope | 12744 |
| Distribution | US Nationwide Distribution |
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-1385-2018) 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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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026