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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640142810353), received between Sep 3, 2022 and Aug 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED DURING A RECANALIZATION PROCEDURE, THE ASPIRATION OF THE DEVICE ALLEGEDLY MISSED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY STUCK IN THE STENT STRAT AND WAS RIPPED BY THE SPINNING CATHETER. REPORTEDLY, GUIDEWIRE PARTS COULD BE RETRIEVED COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597853 ↗
• MalfunctionSep 3, 2022Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA CROSS-OVER APPROACH IN THE RIGHT AFC TO THE LEFT LEG, THE SPINDLE WAS ALLEGEDLY BROKE INSIDE 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 15353523 ↗

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