Bard Peripheral Vascular Inc recalls Rotarex Atherectomy System and Instructions for Use
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm1 code
- 80236
S 6 F x 135 cm1 code
- 80237
S 8 F x 85 cm1 code
- 80238
S 8 F x 110 cm1 code
- 80239
Lot / code information
- 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) — +92 moreShow all
(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)
What the firm is doing
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.
DistributionShow detailsHide
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
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1244-2025
- FDA 510(k) clearance · K172315The device's official FDA premarket clearance record
- FDA 510(k) clearance · K211738The device's official FDA premarket clearance record
- FDA 510(k) clearance · K242757The device's official FDA premarket clearance record
- FDA device classification · MCWOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.4875The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Bard Peripheral Vascular IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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