Rotarex Atherectomy System and Instructions for Use, BD SET… recallZ-1244-2025 · Bard Peripheral Vascular Inc · initiated Feb 5, 2025

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company 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 [email protected] 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: [email protected] For additional information regarding Advance Clinical Education and Training Programs, please email the Advance Team at [email protected] 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.

Recall details

Recall number

Z-1244-2025

Status

Open, Classified

Initiated by the company

Feb 5, 2025

Posted by the FDA

Mar 5, 2025

Recalling firm

Bard Peripheral Vascular Inc

Quantity

15,755

Product code

MCW

FDA submissions

K172315, K211738, K242757

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

Product description

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

• SET Rotarex™S 6 F x 135 cm 80237

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  1 recall79 reports
• SET Rotarex™S 6 F x 110 cm 80236

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  1 recall7 reports
• SET Rotarex™S 8 F x 85 cm 80238

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  1 recall3 reports
• SET Rotarex™S 8 F x 110 cm 80239

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  1 recall2 reports

Other devices under the same FDA submission

13 devices cleared under K172315, K211738, K242757 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• SET Rotarex®S 6F 135cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  2 deaths206 reports
• SET Rotarex®S 6F 110cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  30 reports
• Rotarex®S 6F 135cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  18 reports
• Drive System (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  18 reports
• SET Rotarex®S 8F 110 cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  15 reports
• Rotarex®S 8F 110cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  11 reports
• Rotarex®S 6F 110cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  10 reports
• Guidewire 0.018 4/270cm angled (Straub Medical®) Version 1.0

  Straub Medical AG · Wire, Guide, Catheter
  4 reports
• SET Rotarex®S 8F 85cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  4 reports
• Guidewire 0.018 4/220cm angled (Straub Medical®) Version 1.0

  Straub Medical AG · Wire, Guide, Catheter
  3 reports
• Guidewire 0.018 4/320cm angled (Straub Medical®) Version 1.0

  Straub Medical AG · Wire, Guide, Catheter
  3 reports
• Rotarex®S 8F 85cm (Straub Medical®) Version 1.0

  Straub Medical AG · Catheter, Peripheral, Atherectomy
  2 reports