FDA Device recall Z-3253-2018
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
- FDA Device
- Class III
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class III recall of Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 by Medtronic Vascular, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3253-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-16 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Vascular |
| Distribution | CA, IA, NE, TN, TX, VA, WA |
Product
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Reason
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.
Identifiers
| code_info | UDI/GTIN: 20643169738717 Lot Number 60068186 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3253-2018%22
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