Rotarex®S 6F 110cm (Straub Medical®) Version 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640142810278), received between Apr 22, 2020 and Sep 11, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 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 Hypotension in fatigue. The adverse event relation with the study device and procedure is unknown. The current status of the patient was unknown.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50729382 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ATHERECTOMY AND THROMBECTOMY PROCEDURE, THE CATHETER HELIX WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520264 ↗
• MalfunctionDec 13, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966567 ↗
• MalfunctionNov 24, 2021Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT POST PROCEDURE AND UPON REMOVAL OF THE DEVICE, THE HEAD OF THE DEVICE ALLEGEDLY GOT STUCK IN THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT DUE TO THE FORCE EXERTED IN PULLING OUT THE DEVICE, THE HEAD OF THE CATHETER ALLEGEDLY GOT LOOSE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867340 ↗
• MalfunctionJun 16, 2020Fracture; Break; Fracture

  DURING THE INDEX PROCEDURE FOR PMCF ROTAREX TRIAL THE ROTAREX HEAD IS TORN OFF AND COULD BE REMOVED COMPLETELY WITHOUT TAKING FURTHER ACTIONS.

  Patient problems: Embolism; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient; Perforation of Vessels; Vascular Dissection

  MAUDE report 10158002 ↗
• MalfunctionJun 10, 2020Fracture; Fracture

  THE DOCTOR USED A CONTRALATERAL APPROACH. IT WAS VERY HARD TO PASS THE STENT IN THE SFA AND A.POPLITEA. WHEN WE PASSED THE STENTS AND ARE IN TRUE LUMEN IN POPLITEAL ARTERY WE START TO USE THE ROTAREX 6F 135CM. WE PASSED THE ORIGO OF THE STENT IN SFA SEVERAL TIMES AND THEN THE CATHETER BROKE.

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

  MAUDE report 10138521 ↗
• MalfunctionMay 1, 2020Loss of or Failure to Bond; Fracture; Device Damaged by Another Device; Loss of or Failure to Bond; Break; Fracture; Device Damaged by Another Device; No Flow

  THROMBOSIS WAS FOUND IN SFA. ANTEROGRADE PUNCTURE WAS PERFORMED. STRAUB GUILDWIRE WAS USED. SYRINGE WAS USED TO FLUSH THE CATHETER BEFORE INSERTING INTO THE BODY. GUILDWIRE REACHED 15CM BEYOND THE THROMBOSIS. CATHETER REACHED 2CM BEFORE THE THROMBOSIS AND STARTED THE MOTOR. AT THE BEGINNING, BLOOD WAS FOUND FLOWING OUT. AFTER AROUND ONE MINUTE, NO BLOOD FLOW WAS FOUND. WITHDRAW THE CATHETER, IT WAS FOUND BROKEN AT THE HEAD. PTA WAS USED TO THE PATIENT AND COMPLETE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis

  MAUDE report 10016768 ↗
• InjuryApr 30, 2020Mechanical Jam; Break; Mechanical Jam

  THROMBOSIS WAS FOUND IN SFA. ANTEROGRADE PUNCTURE WAS PERFORMED. STRAUB GUIDEWIRE WAS USED. SYRINGE WAS USED TO FLUSH THE CATHETER BEFORE INSERTING INTO THE BODY. GUIDEWIRE REACHED 15CM BEYOND THE THROMBOSIS. CATHETER REACHED 2CM BEFORE THE THROMBOSIS AND STARTED THE MOTOR. AT THE BEGINNING, BLOOD WAS FOUND FLOWING OUT. AFTER AROUND ONE MINUTE, NO BLOOD FLOW WAS FOUND. BIG RESISTANCE WAS FOUND WHEN TAKING IT OUT. ABOUT 10CM OF THE CATHETER HEAD WAS LEFT IN THE VESSEL. KNIFE AND SCISSORS WERE USED TO TAKE THE BROKEN HEAD OUT. ANOTHER NEW CATHETER WAS USED TO COMPLETE THE OPERATION.

  Patient problems: Device Embedded In Tissue or Plaque; Thrombosis

  MAUDE report 10013263 ↗
• MalfunctionApr 24, 2020Fracture; Use of Device Problem; Fracture; Use of Device Problem

  SLIM PATIENT. LEFT ANTEGRADE APPROACH WITH OCCLUSION TO TRUNK. HELIX HAS BROKEN DURING A SECOND PASS. THIS WAS NOTICED AT THE END. THE PROCEDURE WAS COMPLETED. IT WAS A THIRD PASS WHICH COULD NOT BE DONE. THE RESULT WAS OK. HELIX COULD BE REMOVED FROM THE PATIENT BY PULLING OUT THE SHEATH.

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

  MAUDE report 9997351 ↗
• MalfunctionApr 22, 2020Fracture; Fracture

  ON (B)(6) 2020 @ 15.00 PM. THE DOCTOR PUNCTURE THE FEMALE PATIENT IN THE RIGHT OF FEMORAL ARTERY AND CROSSOVER TO LEFT SFA LESION IN NATIVE VESSEL AND INJECTED HEPARIN 5,000 IU. HE HAS USED ROTAREX 6F 110 CM AFTER 2 PASSED AND HE PULLED IT OUT OF THE PATIENT AND TIP OF HELIX STRETCH OUT AND NOT BACK IN THE CATHETER. THEREFORE, THE DOCTOR CHANGE TO ROTAREX 6F 135 CM AFTER FIRST PASSED AFTER HE PULLED IT OUT OF THE PATIENT AND THE HELIX IS NOT INSIDE THE CATHETER.

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

  MAUDE report 9986006 ↗

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