Z-3253-2018 Class III Terminated
FDA device recall Z-3253-2018 was initiated by Medtronic Vascular on Aug 16, 2018 and is designated Class III. Reason for recall: Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the… The recall status is terminated (terminated May 7, 2021). Affected quantity: 250 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Aug 16, 2018
- Termination Date
- May 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 units
Product Description
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Reason for Recall
Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
Distribution Pattern
CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
Code Information
UDI/GTIN: 20643169738717 Lot Number 60068186
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3253-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026