Intra-Aortic Balloon Catheter Mega 7.5FR 40cc 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.
Reported: April 25, 2018 Initiated: February 21, 2018 #Z-1383-2018
Product Description
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc 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.
Details
- Recalling Firm
- Datascope Corporation
- Units Affected
- 2714
- Distribution
- US Nationwide Distribution
- Location
- Fairfield, NJ
Frequently Asked Questions
What product was recalled? ▼
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc 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.. Recalled by Datascope Corporation. Units affected: 2714.
Why was this product recalled? ▼
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1383-2018.
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