# FDA recall Z-0676-2024

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2023-11-14.

## Product

BD Recanalization System, REF: BDRECANSYSTEM

## Reason for recall

Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.

## Distribution

US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN

## Key facts

- **Recall number:** Z-0676-2024
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-14
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0676-2024

## Citation

> AI Analytics. FDA recall Z-0676-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0676-2024. Source: US FDA. Licensed CC0.

---

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