Z-1383-2018 Class II Terminated
FDA device recall Z-1383-2018 was initiated by Datascope Corporation on Feb 21, 2018 and is designated Class II. Reason for recall: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section. The recall status is terminated (terminated Mar 18, 2020). Affected quantity: 2714.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 25, 2018
- Initiation Date
- Feb 21, 2018
- Termination Date
- Mar 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2714
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.
Distribution Pattern
US Nationwide Distribution
Code Information
0684 00 0295 01U and 0684 00 0295 02U
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1383-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026