SET Rotarex®S 6F 135cm (Straub Medical®) Version 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 07640142810582), received between Jul 4, 2020 and Jul 9, 2026 — classified as 2 deaths, 62 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Break” (142 reports).

1 other recall cover devices cleared under the same FDA submission (K172315, K211738); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT, THE SUBJECT HAD AN ADVERSE EVENT OF DISTAL EMBOLIZATION. THE ADVERSE EVENT WAS PROBABLY RELATED TO THE STUDY DEVICE AND HAD CAUSAL RELATION TO THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Embolism/Embolus

  MAUDE report 25770451 ↗
• MalfunctionOct 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE. DURING ROTAREX CATHETER, THE HELIX ALLEGEDLY HAD FRACTURE. IT WAS FURTHER REPORTED THAT THE FRACTURED HELIX COMPLETELY DETACHED THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400901 ↗
• MalfunctionAug 25, 2025Deformation Due to Compressive Stress; Activation Problem; Deformation Due to Compressive Stress; Activation Problem

  ON (B)(6) 2025 A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE CATHETER FAILED TO ROTATE. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882184 ↗
• MalfunctionAug 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING ROTAREX DEVICE. DURING THE PROCEDURE, DEVICE PASSED THROUGH WITHOUT CLUTCHING, THE HELIX WAS ALLEGEDLY FOUND TO BE BROKEN INSIDE THE PATIENT UPON REMOVING. ABLE TO SNARE AND REMOVE THE REMAINING PIECE WITHOUT HARM TO THE PATIENT. REMOVED THE DEVICE COMPLETED ANGIOPLASTY, HAD A GOOD RESULT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826154 ↗
• MalfunctionJul 1, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE. DURING THE PROCEDURE, THE DEVICE ALLEGEDLY HEATED AND CLUTCHING IN STENT MID SFA. IT WAS FAILED TO CROSS THE LESION. DEVICE WAS REMOVED AND A DIFFERENT DEVICE USED TO COMPLETE THE TREATMENT OF THE ENTIRE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369789 ↗
• InjuryMay 16, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2023, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE IN A TIBIAL ARTERY. DURING THE PROCEDURE, THE CATHETER CREATED A SEVERE DISSECTION THAT REQUIRED PLACEMENT OF A CORONARY COVERED STENT. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 22034558 ↗
• MalfunctionApr 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING ROTAREX CATHETER VIA COMMON FEMORAL ARTERY THROUGH CONTRALATERAL APPROACH. DURING THE PROCEDURE, HELIX WAS ALLEGEDLY FRACTURED IN AN IN-STENT RESTENOSIS CASE. FRACTURED HELIX WAS RETRIEVED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917192 ↗
• MalfunctionApr 22, 2025Deformation Due to Compressive Stress; Mechanical Jam; Deformation Due to Compressive Stress; Mechanical Jam

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER ALLEGEDLY WAS CLOGGED AND STOPPED ASPIRATING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880343 ↗
• MalfunctionApr 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE TIP OF THE CATHETER WAS ALLEGEDLY DETACHED AND WAS IN SHEATH. THE DEVICE AND THE TIP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21803321 ↗
• MalfunctionMar 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE CATHETER HELIX HAD ALLEGEDLY FOUND TO BE NOT INTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705488 ↗
• MalfunctionMar 26, 2025Melted; Melted

  IT WAS REPORTED DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE PROXIMAL PART OF THE CATHETER SHAFT ALLEGEDLY MELTED WHILE PERFORMING A PROCEDURE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695370 ↗
• MalfunctionMar 25, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE DEVICE ALLEGEDLY WOULD NOT SPIN OVER THE WIRE NOR ABLE TO REMOVE DEVICE OVER WIRE SO EVERYTHING DEVICE AND WIRE HAD TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685565 ↗
• MalfunctionMar 21, 2025Retraction Problem; Mechanical Jam; Retraction Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE DEVICE WAS ALLEGEDLY CLUTCHED OUT SEVERAL TIMES. IT WAS FURTHER REPORTED THAT THE WIRE WAS ALLEGEDLY STUCK INSIDE THE CATHETER UPON REMOVING THE DEVICE. THE PROCEDURE WAS COMPLETED USING BALLOONING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662268 ↗
• MalfunctionMar 21, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA COMMON FEMORAL ARTERY THROUGH CONTRALATERAL APPROACH, THE CATHETER ADHERED TO THE GUIDEWIRE WAS ALLEGEDLY FULLY SUBMERGED IN THE BOWL OF SALINE WHEN FLUSHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661104 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER HELIX WAS ALLEGEDLY BROKEN NEAR THE HANDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580691 ↗
• MalfunctionJan 29, 2025Noise, Audible; Physical Resistance/Sticking; Noise, Audible; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT ANTERIOR TIBIAL ARTERY, IT WAS FOUND THAT THERE WAS ALLEGEDLY A HIGH PITCH SQUEAL. IT WAS FURTHER REPORTED THAT THE WIRE OUTSIDE THE PATIENT WAS ALLEGEDLY FOUND TO HAVE A SPUN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263733 ↗
• MalfunctionJan 16, 2025Material Separation; Mechanical Jam; Noise, Audible; Material Separation; Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER ALLEGEDLY MADE HIGH PITCHED NOISE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY CLUTCHED OUT AND WOULDN'T RUN. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY DISENGAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21165532 ↗
• InjuryJan 14, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE HELIX WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE HELIX ALLEGEDLY DETACHED INSIDE THE PATIENT'S BODY. REPORTEDLY, BROKEN DEVICE REMOVED THROUGH THE BYPASS SURGERY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 21146741 ↗
• MalfunctionJan 6, 2025Flushing Problem; Mechanical Jam; Physical Resistance/Sticking; Flushing Problem; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY CONTRALATERAL APPROACH, THE CATHETER WAS ALLEGEDLY STUCK TO THE WIRE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS TAKEN OUT OF THE PATIENT'S BODY AND TRIED TO FLUSH IT IN SALINE, THE CATHETER ALLEGEDLY WOULD NOT CLEAR THE DEBRIS STUCK IN THERE AND DID NOT SEEM TO ASPIRATE PROPERLY. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081915 ↗
• InjuryDec 17, 2024Break; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component; Break; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ATHERECTOMY AND THROMBECTOMY PROCEDURE, THE INTERNAL HELIX WAS ALLEGEDLY FRACTURED AND DETACHED WHILE TREATING IN STENT RESTENOSIS. IT WAS FURTHER REPORTED THAT HELIX WAS ATTEMPTED TO BE RETRIEVED WITH MULTIPLE DIFFERENT TECHNIQUES, EVENTUALLY HELIX WAS SNARED AND PULLED UP INTO AORTA BUT UNABLE TO BE RETRIEVED OUT OF SHEATH, ULTIMATELY THE HELIX HAD TO BE ENDO-TRASHED AND LEFT IN THE PATIENTS BODY. REPORTEDLY, STENTS WERE PLACED OVER THE DETACHED HELIX INTO THE PATIENT'S AORTA AND ILIAC SYSTEM. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 20949235 ↗
• MalfunctionNov 29, 2024Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER WAS ALLEGEDLY UNABLE TO ADVANCE THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE CATHETER TIP ALLEGEDLY BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808730 ↗
• InjuryNov 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE WIRE ALLEGEDLY FRACTURED INTO MULTIPLE PIECES. IT WAS FURTHER REPORTED THAT THE BROKEN PART OF THE DEVICE ALLEGEDLY COULD NOT BE REMOVED; AND THE PATIENT WAS SENT TO OPERATING ROOM FOR REMOVAL. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

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

  MAUDE report 20756921 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER SHAFT ALLEGEDLY HAD BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735655 ↗
• MalfunctionOct 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER HELIX WAS ALLEGEDLY FRACTURED AND DETACHED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS RETRIEVED AS ONE UNIT WITHOUT ANY ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531209 ↗
• InjuryOct 16, 2024Device Handling Problem; Physical Resistance/Sticking; Device Handling Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER ALLEGEDLY GOT STUCK INTO THE WIRE. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY PERFORATED THE POPLITEAL ARTERY. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED EMBOLISM AND BLEEDING. REPORTEDLY, THE ENTIRE WIRE HAD TO BE PULLED TO GET THE CATHETER OUT OF PATIENT'S BODY. THE PATIENT IS REPORTED TO BE STABLE NOW.

  Patient problems: Embolism/Embolus; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 20468137 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172315, K211738. One submission often covers many models, so check the product and lot details in each record.

• Z-1244-2025 · Feb 5, 2025 · Open, Classified
  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