Bard Peripheral Vascular Inc: 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

Recall number

Z-1244-2025

Recalling firm

Bard Peripheral Vascular Inc

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

Status

Open, Classified

Initiated

2025-02-05

Posted

2025-03-05

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

On 2/5/2025, "URGENT: MEDICAL DEVICE CORRECTION" notices were sent to customers informing them of the following: 1) In order to minimize risks of illness or injury, please review the updates to the eIFU in their entirety. The updated eIFU can be found on BD's website at https://www.bardpv.com/Rotarex-IFU.php 2) Firm recommends that end users review the updated on-line, on-demand training on the safe and effective use of the Rotarex Atherectomy System, reflecting the recent eIFU updates. The online education may be completed by registering on the BDLA Learning Management System https://academy.bd.com. 3) If possible, post this notice with the stored product as evidence of the updated eIFU. 4) Share this notification with all users within your facility network of the product to ensure they are also aware of the updated eIFU. This correction notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 5) Complete and return the response form via email to BDRC20@bd.com Report any complaints experienced with the use of this product to the firm's Regional Complaint Center: 1-844-8BD-LIFE (1-844-823-5433) Say "Product Complaints" when prompted Mon-Fri 8:00am to 5:00pm CT Email: productcomplaints@bd.com For additional information regarding Advance Clinical Education and Training Programs, please email the Advance Team at bdpi.advance@bd.com Distributors were provided with a copy of the customer communication (correction notice) and asked to provide a copy to all customers on BD's behalf. If you have any questions, call 480-303-2602.

Quantity

15,755

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

Lot, serial or model codes

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), 240531(2027-01-10), 240566(2027-01-10), 240568(2027-01-25), 240754(2027-02-06), 240769(2027-02-09), 240795(2027-03-04), 241074(2027-03-07), 241119(2027-03-21), 241190(2027-04-16), 241325(2027-04-16), 241328(2027-04-25), 241336(2027-04-29), 241464(2027-05-07), 241471(2027-05-27), 241553(2027-06-05), 242019(2027-06-28), 242023(2027-06-12), 242057(2027-06-20), 242056(2027-06-20), 242112(2027-06-26), 242160(2027-07-25), 242321(2027-07-08), 242493(2027-08-01), 242596(2027-09-20), 242693(2027-11-06); 80238/07640142811879/230895(2025-11-23), 240128(2026-05-31), 240276(2026-05-31), 240532(2026-05-31), 240658(2026-09-30), 241076(2026-09-30), 241330(2026-09-30), 241548(2026-09-30), 241768(2026-09-30), 241911(2026-09-30), 242117(2026-09-30), 242494(2026-09-30), 242521(2026-09-30), 242519(2026-05-31), 242520(2026-09-30); 80239/07640142811886/230896(2025-11-23), 231231(2026-06-13), 231410(2026-06-13), 231527(2026-08-31), 231883(2026-10-19), 232029(2026-08-31), 232028(2026-10-19), 240129(2026-11-30), 240278(2026-11-30), 240557(2027-01-22), 240746(2027-01-22), 240794(2027-02-28), 241077(2027-04-08), 241188(2027-04-08), 241462(2027-05-03), 241523(2027-05-03), 241767(2027-06-26), 241910(2027-06-26), 242159(2027-08-09), 242322(2027-09-10), 242518(2027-09-10), 242694(2027-10-25), 242695(2027-10-25)

510(k) numbers

["K172315","K211738","K242757"]

PMA numbers

not on file

Product code

MCW

Firm FEI

2020394

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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