SET Rotarex™S 6 F x 135 cm 80237Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 07640142811862), received between Mar 13, 2023 and Sep 22, 2026 — classified as 12 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  On (b)(6) 2026, a patient underwent a thrombectomy and atherectomy procedure using a Rotarex device. During the procedure, the helix fractured after the sheath was protracted into the aorta. The procedure was completed successfully. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853250 ↗
• MalfunctionSep 22, 2026Retraction Problem

  A patient underwent a thrombectomy and atherectomy procedure using a Rotarex device. During the use, the customer reported that one catheter required manual extraction from the patients skin. According to the customer, the device did not disengage as expected and had to be physically removed. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852676 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  It was reported through the results of clinical trial ((b)(4)) that the subject underwent revascularization of a non-target limb while participating in the XTRACT study. The patient's current status is unknown.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50836518 ↗
• MalfunctionSep 10, 2026Break; Detachment of Device or Device Component

  On (b)(6) 2026, a patient underwent a thrombectomy and atherectomy procedure using a Rotarex device for the treatment of peripheral artery disease (PAD) involving the mid and proximal superficial femoral artery (SFA). During the procedure, it was reported that the device was being used as intended when an unexpected product failure occurred. Approximately 8 inches of the distal tip component separated, and the component fractured while the device was being withdrawn from the patient through the hemostatic valve. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707608 ↗
• MalfunctionSep 8, 2026Break

  On (b)(6) 2026, a patient was prepped for a thrombectomy and atherectomy procedure using a Rotarex catheter. Prior to the procedure, the helix was found fractured within the handle, preventing the guidewire from passing through the handle and out the back of the device. The issue was identified during the initial flushing of the catheter or upon opening the device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667739 ↗
• InjuryAug 19, 2026Break; Noise, Audible

  On (b)(6)2026, a patient underwent a thrombectomy and atherectomy procedure using a Rotarex device for the treatment of a superficial femoral artery (SFA) occlusion. During the procedure, while the catheter was traversing approximately 75 percent of the occlusion, an abnormal audible noise was noted. The catheter was subsequently withdrawn, and inspection revealed that the internal helix had fractured. It was further reported that the catheter tip and a portion of the fractured helix remained within the patient. Retrieval of the retained fragment was successfully performed by intertwining a 0.014-inch guidewire with the distal portion of the fractured helix and withdrawing it through the sheath via the original access site. An attempted retrieval using a snare technique was unsuccessful. The retrieval process was reported to be prolonged and technically challenging. Following successful fragment retrieval, the procedure was completed with placement of three stents in the SFA. The patient's current status is unknown.

  Patient problems: Foreign Body In Patient

  MAUDE report 50322796 ↗
• InjuryAug 6, 2026Break

  On (b)(6) 2024, a patient underwent a thrombectomy and atherectomy procedure using a Rotarex Catheter. During the procedure, the catheter fractured, leaving a device fragment inside the patient. Multiple retrieval attempts, including the use of a snare, were unsuccessful. The guidewire, foreign object, and sheath were subsequently removed together. During sheath removal, a hematoma developed due to difficulty achieving hemostasis. A smaller sheath and a closure device were used, and the patient was admitted for observation. A repeat procedure was planned.

  Patient problems: Foreign Body In Patient; Hematoma

  MAUDE report 50152180 ↗
• MalfunctionAug 4, 2026Break; Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125519 ↗
• MalfunctionJul 27, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020951 ↗
• InjuryJul 15, 2026Break; Unraveled Material; Mechanical Jam; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE FUSED WITH THE CATHETER AND THE HELIX BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 25824107 ↗
• InjuryJul 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT DURING THE INDEX PROCEDURE, THE SUBJECT HAD AN ADVERSE EVENT OF NON FLOW LIMITING DISSECTIONS OF OSTIAL SUPERFICIAL FEMORAL ARTERY INDEX LEG. THE ADVERSE EVENT WAS NOT RELATED TO THE DEVICE BUT CAUSALLY RELATED TO THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 25777852 ↗
• MalfunctionJul 9, 2026Material Deformation; Mechanical Jam

  On (b)(6)2026, a 60-year-old female patient underwent a thrombectomy and atherectomy procedure using a Rotarex device in the superficial femoral artery (SFA). During the procedure, it was reported that the Rotarex device lost aspiration functionality. The device was withdrawn from the patient and flushed, at which time an abnormality was observed at the catheter tip. The device was removed without difficulty. The procedure was subsequently completed successfully using an alternative device, specifically a laser. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764198 ↗
• InjuryJul 3, 2026Migration or Expulsion of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE FOR A LEFT SFA OCCLUSION. DURING THE SECOND PASS, THE DEVICE DREW IN THE VESSEL WALL AND CAUSED A PERFORATION OF THE LEFT SFA. THE PATIENT REQUIRED PLACEMENT OF A COVERED STENT TO REPAIR THE PERFORATION. THE PATIENTS CURRENT CONDITION IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 25706713 ↗
• InjuryJul 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT ONE MONTH AND THIRTEEN DAYS LATER SUBJECT HAD ADVERSE EVENT OF RIGHT LOWER EXTREMITY ISCHEMIA AND THROMBOSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 25703987 ↗
• MalfunctionJul 1, 2026Break; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE WAS SEPARATED, LEAVING A FRAGMENT RETAINED IN THE PATIENT. ALL DEVICES WERE SUBSEQUENTLY REMOVED, RESULTING IN LOSS OF ACCESS. THE ISSUE OCCURRED AFTER A SINGLE PASS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679131 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported through the results of the clinical trial (b)(4) that during the index procedure, the subject had an adverse event of distal embolization. The relationship to study device was probable and relationship to procedure is possible. The current status of the patient was unknown.

  Patient problems: Embolism/Embolus

  MAUDE report 25558935 ↗
• MalfunctionJun 2, 2026Overheating of Device

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT, ON (B)(6) 2026, THE PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX CATHETER, DURING WHICH THE CATHETER WAS ALLEGED TO HAVE OVERHEATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25357926 ↗
• MalfunctionJun 1, 2026Break; Mechanical Jam

  ON (B)(6) 2026, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. DURING THE PROCEDURE, REPORTEDLY IT SUCKED UP A LARGE CHRONIC PIECE AND CAUSED IT TO FAIL. IT STOPPED ASPIRATING AND SPINNING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25346789 ↗
• MalfunctionMay 25, 2026Mechanical Jam; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. DURING THE PROCEDURE THE ROTAREX MOTOR CLOGGED AND KEPT CLUTCHING OUT AFTER FLUSHING THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270019 ↗
• MalfunctionMay 21, 2026Detachment of Device or Device Component; Mechanical Jam; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX CATHETER. DURING THE PROCEDURE, THE CATHETER BECAME CLOGGED, DURING WITHDRAWAL FOR FLUSHING, THE CATHETER TIP BEGAN SEPARATING, AND THE DEVICE BECAME STUCK ON THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240542 ↗
• MalfunctionMay 18, 2026Break

  ON (B)(6), 2026, A PATIENT UNDERWENT AN ILIAC ARTERY ANGIOPLASTY PROCEDURE USING THE ROTAREX CATHETER. DURING THE PROCEDURE, THE ROTAREX CATHETER FRACTURED DURING USE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197776 ↗
• InjuryMay 15, 2026Break; Fracture; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. IT WAS REPORTED THAT THERE WAS A HELIX FRACTURE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 25183423 ↗
• MalfunctionMay 8, 2026Stretched; Mechanical Jam

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE FOR IN STENT RESTENOSIS (ISR) OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. DURING THE FIRST PASS, THE CATHETER MOTOR BECAME CLOGGED. THE CATHETER WAS WITHDRAWN FOR FLUSHING; HOWEVER, THE DISTAL TIP PULLED OUT AND COULD NOT BE RETRACTED BACK INTO THE CATHETER HOUSING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123118 ↗
• MalfunctionMay 6, 2026Break; Stretched

  ON (B)(6) 2026, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE THEY STOPPED USING DUE TO TIP EXTENUATING, COMPLETED CASE WITH TS UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091567 ↗
• MalfunctionMay 4, 2026Break; Flushing Problem; Activation Failure; Noise, Audible; Activation Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX CATHETER. PRIOR TO THE PROCEDURE, WHEN FLUSHED WITH SALINE, NO FLUID ENTERED THE COLLECTION BAG TUBING. THE CATHETER PRODUCED ACTIVATION NOISE, BUT THE CATHETER HEAD DID NOT ROTATE DESPITE MULTIPLE CONNECTION AND ACTIVATION ATTEMPTS. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25065641 ↗