# FDA recall Z-1257-2021

> **Cordis Corporation** · Class I · device recall initiated 2021-02-11.

## Product

PRECISE PRO RX CAROTID STENT implant system, Product Codes:  PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC

## Reason for recall

Distal tip may become separated from the lumen wire in specific lots.

## Distribution

US (except MT and NM) and Taiwan

## Key facts

- **Recall number:** Z-1257-2021
- **Recalling firm:** Cordis Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-02-11
- **Report date:** 2021-03-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1257-2021

## Citation

> AI Analytics. FDA recall Z-1257-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-1257-2021. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*