SET Rotarex™S 6 F x 110 cm 80236Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640142811855), received between Mar 17, 2025 and Aug 27, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 5, 2025Class IOpen, Classified

   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.

   Z-1244-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Insufficient Device Problem Information

  It was reported through the results of the clinical trial (b)(4) that on (b)(6)2026, the subject had an adverse event of Major Flow Limiting Dissection, Grade D. There is a possible relationship with the device and probable relationship with the procedure. The current status of the patient was unknown.

  Patient problems: Vascular Dissection

  MAUDE report 50468917 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144049 ↗
• InjuryAug 5, 2026Insufficient Device Problem Information

  It was reported through the results of the clinical trial (b)(4) that on (b)(6) 2026, the subject had an adverse event of not documented grade right common femoral artery dissection. The adverse event was possibly related to the study device and procedure. The current status of the patient was unknown.

  Patient problems: Vascular Dissection

  MAUDE report 50137681 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL (BDPI-25-001) THAT DURING THE INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF DISTAL EMBOLIZATION IN POPLITEAL BIFURCATION AND DISTAL ASPECT OF THE ANTERIOR TIBIAL ARTERY. THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Embolism/Embolus

  MAUDE report 25662971 ↗
• MalfunctionMay 26, 2026Break; Activation Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE. DURING THE PROCEDURE, THE GUIDEWIRE WAS FOUND CUT ON BOTH SIDES AT THE DISTAL END OF THE SECOND STENT. THE FLOPPY TIP REMAINED IN THE KNEE AND WAS SEVERED, WHILE ANOTHER SECTION WAS CUT WITHIN THE DESTINATION SHEATH AND SUCCESSFULLY RETRIEVED. THE CUTS OCCURRED IN AREAS WHERE THE CATHETER CUTTING HEAD WAS NOT ACTIVATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25275318 ↗
• MalfunctionOct 16, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. DURING THAT LIVE TRAINING CASE THE HELIX WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307713 ↗
• MalfunctionMar 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE HELIX OF THE CATHETER ALLEGEDLY HAD COME DETACHED BEFORE PUTTING IT INTO THE SHEATH AND THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617516 ↗