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

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07640142810292), received between Apr 20, 2020 and Jun 24, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K172315); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Retraction Problem; Deformation Due to Compressive Stress; Material Deformation

  ON (B)(6) 2025, A 60-YEAR-OLD MALE PATIENT UNDERWENT PERCUTANEOUS FEMORAL ARTERY THROMBECTOMY AND ENDOVASCULAR ANGIOPLASTY FOR ULCERATION OF THE SECOND TOE OF THE RIGHT FOOT FOR MORE THAN A MONTH USING A ROTAREX 6F 135CM CATHETER. DURING THE PROCEDURE, THE CATHETER SUCTIONED FROM THE SUPERFICIAL FEMORAL ARTERY TO THE FEMORAL POPLITEAL ARTERY THREE TIMES, AND THE BODY OF THE TUBING WAS FOUND TO BE BENT, AND THE DEVICE WAS DIFFICULT TO REMOVE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313391 ↗
• MalfunctionApr 17, 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 DEVICE ALLEGEDLY HAD BROKEN. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY DETACHED. REPORTEDLY, THE DETACHED PART WAS REMOVED USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856753 ↗
• MalfunctionMar 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE LEFT EXTERNAL ILIAC ARTERY VIA CONTRALATERAL APPROACH, THE TIP OF THE DEVICE ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DETACHED. REPORTEDLY, THE DETACHED PART COULD BE SNARED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686084 ↗
• MalfunctionJan 13, 2025Melted; Material Deformation; Mechanical Jam; Melted; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER HEAD ALLEGEDLY BURNED OUT AND STOPPED WORKING BECAUSE OF POOR CONTACT BETWEEN THE HANDLE CORD AND THE MACHINE'S INTERFACE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21134875 ↗
• InjuryApr 8, 2024Break; Mechanical Jam; Break; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057222 ↗
• MalfunctionDec 29, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE MODERATELY CALCIFIED LESION VIA THE CROSSOVER APPROACH, THE HELIX WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT THE HELIX WAS ALLEGEDLY FOUND TO BE DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417744 ↗
• MalfunctionOct 31, 2023Break; Retraction Problem; Detachment of Device or Device Component; Mechanical Jam; Break; Retraction Problem; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE GROIN ACCESS AS THE BLOOD FLOW WAS PARTIALLY RESTORED AFTER THE FIRST SUCTION, THE SURGEON DECIDED TO CONTINUE THE SUCTION AND DURING THE SUCTION, THE COILED SPRING INSIDE THE CATHETER SUDDENLY BROKE WITH THE GUIDE WIRE BEING INTACT. IT WAS FURTHER REPORTED THAT, GREAT RESISTANCE WAS ENCOUNTERED DURING THE WITHDRAWAL OF THE COILED SPRING. FURTHERMORE, THE SURGEON REPEATEDLY ADJUSTED THE ANGLE AND STRENGTH, AND THE COILED SPRING AT THE PROXIMAL END OF THE CATHETER AND THE ENTIRE OUTER CATHETER WAS SUCCESSFULLY WITHDRAWN, WHILE THE DISTAL SPRING AND THE ROTARY CUTTING HEAD END REMAINED IN THE BODY. REPORTEDLY, AFTER THE SURGEON TREATMENT, THE DISTAL SPRING AND ROTARY CUTTING HEAD END TOGETHER WITH THE OUTER SHEATH WITHDRAWN FROM THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037345 ↗
• MalfunctionJul 10, 2023Retraction Problem; Material Deformation; Mechanical Jam; Retraction Problem; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF CATHETER WAS ALLEGEDLY OUT OF SHAPE AFTER FIRST ROUND OF USE. IT WAS FURTHER REPORTED THAT DEVICE CANNOT REMOVE FROM THE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285606 ↗
• MalfunctionMar 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SPRING AT THE TIP POSITION OF THE FRONT END HAD ALLEGEDLY LOST ITS ELASTICITY AND COMPLETELY SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477720 ↗
• MalfunctionFeb 9, 2023Retraction Problem; Component or Accessory Incompatibility; Mechanical Jam; Retraction Problem; Component or Accessory Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY HAD RETRACTION PROBLEM. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY UNABLE TO BE ADVANCED OVER THE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330778 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN DISTAL FEMORAL ARTERY VIA CROSSOVER APPROACH, THE TIP OF THE HELIX ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT BROKEN HELIX TIP WAS REMOVED USING ANOTHER DEVICE. THE PATIENT IS REPORTEDLY STABILIZED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136557 ↗
• MalfunctionJan 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN DISTAL FEMORIAL ARTERY VIA CROSSOVER APPROACH, THE TIP OF THE ROTAREX HELIX ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT FOGARTY CATHETER WAS USED TO REMOVE THE DEVICE. THE PATIENT IS REPORTEDLY STABILIZED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136554 ↗
• MalfunctionJul 1, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA THE RIGHT GROIN , THE CATHETER WAS ALLEGEDLY STUCK ON THE WIRE. IT WAS FURTHER REPORTED THAT THE HELIX WAS UNATTACHED TO THE CATHETER AND STRETCHED OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883296 ↗
• MalfunctionApr 26, 2022Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, A PIECE OF THE CATHETER WAS ALLEGEDLY BROKEN WITHIN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14206347 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159300 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY HAD MALFUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14158897 ↗
• MalfunctionSep 30, 2021Break; Entrapment of Device; Difficult to Remove

  PATIENT UNDERWENT AORTOGRAM AND LEFT LEG ARTERIOGRAM IN MY OFFICE BASED CATH LAB TODAY. DURING ATTEMPTED ATHERECTOMY OF A COMPLETE OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY WITH A STRAUB MEDICAL ROTAREX 6F ATHERECTOMY DEVICE, THE DEVICE BROKE, LEAVING THE CUTTER HEAD AND A LONG PIECE OF THE DRIVING APPARATUS INSIDE THE PATIENT. ATTEMPTS TO SNARE AND RETRIEVE THE BROKEN FRAGMENT VIA THE EXISTING RIGHT COMMON FEMORAL ARTERY ACCESS WERE UNSUCCESSFUL. THE DEVICE WAS ULTIMATELY SNARED AND RETRIEVED SUCCESSFULLY VIA A 2ND SHEATH PLACED IN THE LEFT COMMON FEMORAL ARTERY, BUT A STENT THAT WAS PLACED IN THE LEFT EXTERNAL ILIAC ARTERY DURING THE SAME PROCEDURE WAS ALSO INADVERTENTLY RETRIEVED WITH THE DEVICE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12561869 ↗
• MalfunctionApr 20, 2020Fracture; Fracture

  DOCTOR WAS PUNCTURE AT R FEMORAL ARTERY TO CROSSOVER TO LEFT FEMORAL ARTERY. THE PATIENT WAS INJECTED 5,000 IU OF HAPARIN AS STARTED. ROTAREX WAS USED AT 1ST PASS WITH GOOD FLOW AND GOOD PROGRESSION THEN ROTAREX WAS USED AT 2ND PASSED WITH FLOW RATE LOWER THAN 1ST PASSED.TIME WERE USED OF EACH PASSED APPROX 1 MIN WITH FORWARD AND BACKWARD AS USUAL. AFTER 2ND PASSES DOCTOR WAS FIND WITH ROTAREX THEN SHE PLANED TO DO PTA SO SHE WITHDRAW THE CATHTER OUT THEN SHE FOUND A HELIX WAS BROKEN.

  Patient problems: Embolism; Perforation of Vessels; Vascular Dissection

  MAUDE report 9977140 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172315. 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