# FDA recall Z-3253-2018

> **Medtronic Vascular** · Class III · device recall initiated 2018-08-16.

## Product

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

CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand

## Key facts

- **Recall number:** Z-3253-2018
- **Recalling firm:** Medtronic Vascular
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-16
- **Report date:** 2018-10-03
- **Termination date:** 2021-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3253-2018

## Citation

> AI Analytics. FDA recall Z-3253-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-3253-2018. Source: US FDA. Licensed CC0.

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