SET Rotarex®S 8F 85cm (Straub Medical®) Version 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640142810599), received between Mar 11, 2021 and Oct 14, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE WIRE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT THE MULTIPLE ATTEMPTS OF RETRIEVING THE FRACTURED WIRE WERE ATTEMPTED BUT WITH NO SUCCESS. REPORTEDLY, PATIENT WAS SENT TO A HOSPITAL WHERE IR PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE FRACTURED WIRE AND PATIENT WAS DISCHARGED. ADDITIONALLY, SNARE AND ENDOVASCULAR FORCEPS WERE USED AT THE CENTER FOR THE RETRIEVAL ATTEMPT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 15606883 ↗
• MalfunctionMar 10, 2022Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER OF THE DEVICE ALLEGEDLY GOT STUCK ON THE WIRE AND WAS UNABLE TO MOVE THE CATHETER IN EITHER DIRECTION. THE ENTIRE SYSTEM WAS REMOVED OFF 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 13717466 ↗
• InjuryNov 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN IN THE VESSEL OF THE PATIENT. THE BROKEN CATHETER WAS REMOVED BY SNARE KIT. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED BLEEDING WHICH WAS TREATED WITH THE ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12793164 ↗
• MalfunctionMar 11, 2021Loss of or Failure to Bond; Device Damaged by Another Device; Loss of or Failure to Bond; Entrapment of Device; Overheating of Device; Difficult to Remove; Device Damaged by Another Device; Material Deformation

  DOCTOR WAS PERFORMING A DECLOT. AT OR AROUND 1 MINUTE OF RUNNING THE ROTAREX, THE SCRUB TECH STATED THAT THE WIRE WAS FEELING HOT. I ASKED DOCTOR TO STOP AND REASSESS WHICH HE DID. AS HE WAS REMOVING THE CATHETER HE FELT THAT THE WIRE WAS HARD TO MANIPULATE. AFTER HE FINALLY REMOVED THE CATHETER AND WIRE, HE NOTICED THAT THE TIP OF THE WIRE WAS MANGLED. HE USED FLUOROSCOPY TO SEARCH FOR ANY WIRE FRAGMENTS UPON WHICH HE LOCATED. AFTER MULTIPLE ATTEMPTS TO RETRIEVE WIRE FRAGMENT IT WAS DETERMINED THAT THERE WAS NO IMMEDIATE OR FUTURE HARM TO THE PATIENT AND DECIDED TO CONTINUE WITH THE COMPLETION OF THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462036 ↗

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