Z-1479-2018 Class II Terminated
FDA device recall Z-1479-2018 was initiated by Medtronic Vascular on Mar 13, 2018 and is designated Class II. Reason for recall: The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item… The recall status is terminated (terminated May 7, 2021). Affected quantity: 855 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Mar 13, 2018
- Termination Date
- May 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 855 units
Product Description
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Reason for Recall
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
Distribution Pattern
US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Code Information
UDI 20643169689309, Lot Number 60074805
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1479-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026