SET Rotarex™S 8 F x 85 cm 80238Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640142811879), received between May 26, 2022 and Mar 10, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 5, 2025Class IOpen, Classified

   Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.

   Z-1244-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Material Deformation

  A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ROTAREX DEVICE. DURING THE PROCEDURE, THE CATHETER WAS PLACED ON THE FIELD, BUT UPON INSPECTION, THE END OF THE DEVICE WAS FOUND TO BE BENT, PREVENTING INSERTION OF THE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556100 ↗
• MalfunctionOct 9, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING THE PREPARATION OF A RECANALIZATION PROCEDURE, THE TIP OF THE CATHETER ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE WIRE ALLEGEDLY FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17893882 ↗
• MalfunctionMay 26, 2022Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETERS SPLITED IN TO PIECES WHEN REMOVING THE DEVICE OUTSIDE THE BODY FROM THE SHEATH . THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515785 ↗