SET Rotarex®S 8F 110 cm (Straub Medical®) Version 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07640142810605), received between Oct 29, 2021 and Mar 24, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY WAS DAMAGED OUTSIDE THE BOX. IT WAS FURTHER REPORTED THAT THE HELIX OF THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675125 ↗
• InjuryNov 14, 2024Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE HELIX PART OF THE CATHETER ALLEGEDLY BROKE GOT CAUGHT WITH AN IMPLANTED STENT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY NO EASY TO REMOVE FROM THE PATIENT. REPORTEDLY, THE GROIN OF THE OPPOSITE LEG WAS CUT DOWN AND A SNARE WAS USED TO REMOVE THE CATHETER. HOWEVER, THE CURRENT STATUS OF PATIENT IS UNKNOWN.

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

  MAUDE report 20680230 ↗
• MalfunctionNov 12, 2024Break; 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE HELIX PART OF THE CATHETER ALLEGEDLY BROKE. REPORTEDLY, THE BROKEN PART OF THE CATHETER WAS REMOVED USING A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663798 ↗
• MalfunctionMay 29, 2024Failure to Advance; Deformation Due to Compressive Stress; Material Deformation; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE MID LEFT SUPERFICIAL ARTERY, THE CATHETER ALLEGEDLY WOULD NOT ADVANCE AND KINKED. REPORTEDLY, THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19413646 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE DEVICE ALLEGEDLY BROKE WHEN IT WAS REMOVED AFTER USING IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169880 ↗
• MalfunctionJan 26, 2024Retraction Problem; Stretched; Mechanical Jam; Retraction Problem; Stretched; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE RIGHT FEMORAL ARTERY VIA THE LEFT FEMORAL ACCESS, WHEN THE PHYSICIAN RETRACTED THE DEVICE OUT OF THE SHEATH, THE TIP OF THE DEVICE AND THE INNER HELIX ALLEGEDLY STRETCHED APART MORE THAN THE NORMAL. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE RETRIEVED THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587048 ↗
• MalfunctionNov 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE CATHETER WAS ALLEGEDLY BROKEN OFF AND UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117015 ↗
• MalfunctionMay 9, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE FOR THROMBOSED STENT IN COMMON FEMORAL VIA CONTRALATERAL GROIN ACCESS, THE TIP OF THE CATHETER ALLEGEDLY DETACHED FROM THE CATHETER ONCE THE DEVICE WAS STARTED RUNNING IN A NON-CALCIFIED SEGMENT FOR APPROXIMATELY 3 SECONDS. IT WAS FURTHER REPORTED THAT CATHETER STILL MAINTAINED BARELY ATTACHED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895322 ↗
• MalfunctionApr 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE HELIX WAS ALLEGEDLY BROKEN WHILE RUNNING BEFORE WITH A CLUTCH OUT OF THE DEVICE. THE FRACTURED HELIX WAS NOTICED ON THE REMOVAL OF THE DEVICE. THE DEVICE WAS REMOVED SAFELY AND PATIENT OUTCOMES WERE SUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805245 ↗
• MalfunctionApr 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE THROUGH COMMON FEMORAL ARTERY, THE DEVICE WAS INSERTED OVER THE WIRE THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ACTIVATED AND ENGAGED WITH THE CLOT AND CLUTCHED OUT. FURTHERMORE, THE DEVICE WAS REMOVED TO BE FLUSHED AND, UPON REMOVAL OF THE CATHETER, THE DISTAL TIP AND HELIX OF THE CATHETER REMAINED IN THE SHEATH. UNDER FLUOROSCOPY, IT WAS ALLEGEDLY FOUND THAT THE HELIX WAS FRACTURED AND SEPARATED FROM THE CATHETER. REPORTEDLY, THE DEVICE WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748370 ↗
• MalfunctionJul 5, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, THE DEVICE ALLEGEDLY CLUTCHED OUT. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY HAD A KINK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913690 ↗
• MalfunctionJun 30, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE HELIX WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT BROKEN HELIX WAS STUCK AND REMAINED IN GUIDEWIRE. REPORTEDLY THE SEGMENTS WERE REMOVED WITH BALLOON TECHNIQUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14871523 ↗
• MalfunctionApr 4, 2022Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY UNABLE TO ADVANCE. IT WAS FURTHER REPORTED THAT AN X-RAY EXAMINATION DEMONSTRATED THAT TIP OF THE CATHETER WAS SEPARATED AND STILL INTACT WITH CATHETER. THE CATHETER WAS REMOVED FROM PATIENT AND PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13993248 ↗
• MalfunctionDec 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA FISTULA OF THE ARM, THE WIRE ALLEGEDLY GET STUCK IN CATHETER DUE TO DENSE CLOT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965902 ↗
• MalfunctionOct 29, 2021Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DURING THE PROCEDURE IN RIGHT COMMON FEMORAL, INNER HELIX ALLEGEDLY SEPARATED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12717018 ↗

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