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FDA · Medical devicesClass I

Bard Peripheral Vascular Inc medical device recall: Rotarex Atherectomy System and Instructions for Use

Lead

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
96174
Recall initiated
Feb 5, 2025
Classified by FDA
Mar 5, 2025
Posted in Enforcement Report
Mar 12, 2025
Recalling firm
Bard Peripheral Vascular Inc
Firm location
Tempe, AZ, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Feb 5, 2025. FDA classified it 28 days later, on Mar 5, 2025. Distribution reported by FDA: 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 Bard Peripheral Vascular Inc has 57 recalls in our records.

Recalled products (1)

  • Z-1244-2025 Class I Ongoing

    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

    Codes / lots: Instructions for Use versions prior to ZE10895 revision C1 09/24. REF/UDI-DI/Lot(Expiration): 80236/07640142811855/230893(2025-12-15), 231100(2026-06-09), 231172(2026-06-09), 231171(2026-06-09), 231526(2026-08-21), 231875(2026-08-21), 240018(2026-11-22), 240017(2026-11-22), 240375(2027-01-18), 240567(2027-01-18), 241075(2024-05-22), 241335(2024-06-19), 241550(2024-07-19), 241777(2024-08-19), 242691(2024-12-13); 80237/07640142811862/230897(2026-04-11), 230898(2026-04-11), 231033(2026-05-31), 231101(2026-06-13), 231170(2026-06-13), 231229(2026-07-07), 231400(2026-07-14), 231414(2026-07-31), 231412(2026-06-30), 231413(2026-07-31), 231411(2026-08-03), 231521(2026-09-01), 231520(2026-07-31), 231522(2026-08-31), 231523(2026-09-01), 231524(2026-09-01), 231525(2026-09-01), 231715(2026-09-22), 231885(2026-09-22), 231884(2026-10-27), 240020(2026-11-22), 240396(2026-12-08), 240530(2027-01-10),…

    Quantity: 15,755

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 96174
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.