# FDA recall Z-1244-2025

> **Bard Peripheral Vascular Inc** · Class I · device recall initiated 2025-02-05.

## Product

Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:  S 6 F x 110 cm, REF: 80236;  S 6 F x 135 cm, REF: 80237;  S 8 F x 85 cm, REF: 80238;  S 8 F x 110 cm, REF: 80239

## Reason for recall

Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.

## Distribution

US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND, AZ, SC, TN, UT, AR, WI, SD, MA, MO, ME, DE, WV , NV, NH, MN, CT, NE, IA, NM, WA, HI, and OK

## Key facts

- **Recall number:** Z-1244-2025
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-05
- **Report date:** 2025-03-12

- **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-1244-2025

## Citation

> AI Analytics. FDA recall Z-1244-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1244-2025. Source: US FDA. Licensed CC0.

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