Peripheral ROTAPRO™ H749395141500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506007126), received between Dec 30, 2025 and Jun 10, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Intermittent Loss of Power” (2 reports).

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.

• InjuryJun 10, 2026Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT DEVICE ENTRAPMENT OCCURRED REQUIRING INTERVENTION. A PATIENT PRESENTED FOR ENDOVASCULAR INTERVENTION. ULTRASOUND GUIDED ACCESS WAS INITIALLY OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY (CFA) FOR THE PRIMARY INTERVENTION. FOLLOWING DEVICE ENTRAPMENT, ADDITIONAL RETROGRADE ACCESS WAS OBTAINED VIA THE RIGHT POSTERIOR TIBIAL ARTERY (PTA) TO FACILITATE DEVICE RETRIEVAL. CO2 ANGIOGRAPHY REVEALED TOTAL OCCLUSION IN THE PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY, WITH SINGLE VESSEL RUNOFF VIA THE PERONEAL ARTERY. PTA WAS OCCLUDED IN THE MIDPORTION, AND THE ANTERIOR TIBIAL ARTERY WAS OCCLUDED PROXIMALLY WITH DISTAL RECONSTITUTION. THE LESIONS IN THE SFA AND POPLITEAL ARTERY WERE CROSSED WITH DIFFICULTY USING A NON-BSC WIRE AND A NON-BSC CATHETER. A ROTAWIRE (BOSTON SCIENTIFIC BSC) WAS PLACED IN THE DISTAL PTA AND ROTATIONAL ATHERECTOMY WAS PERFORMED USING A 1.5 MM ROTABLATOR (BOSTON SCIENTIFIC BSC) BURR. DURING ATHERECTOMY OF PTA, THE BURR BECAME LODGED IN THE DISTAL SEGMENT AND COULD NOT BE RETRIEVED USING STANDARD METHODS. A NOVEL RETRIEVAL TECHNIQUE WAS EMPLOYED TO RESOLVE THIS COMPLICATION. UNDER ULTRASOUND GUID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459237 ↗
• MalfunctionDec 30, 2025Device-Device Incompatibility; Output below Specifications; Intermittent Loss of Power; Device-Device Incompatibility; Output below Specifications; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY SUPERFICIAL FEMORAL ARTERY (SFA). A 1.50 MM PERIPHERAL ROTAPRO BURR-ADVANCER, SET AT A ROTATION SPEED OF 170,000 RPM, WAS SELECTED FOR TREATMENT OF THE DISEASED AREA LOCATED WITHIN AN EXISTING STENT. THE BURR WAS ADVANCED TO THE LESION, REACHING SPEEDS OF 165,000 -168,000 RPM, AND BECAME CAUGHT IN THE STENT STRUTS RESULTING IN A STALL. AFTER SEVERAL MINUTES OF MANIPULATING THE DEVICE, THE BURR BROKE FREE OF THE STENT AND WAS REMOVED IN DYNGLIDE MODE VIA THE ROTAWIRE. INTERVENTION WAS CONTINUED BY ADVANCING A BALLOON AND STENT OVER THE ROTAWIRE TO COMPLETE THE PROCEDURE. THE PATIENT FULLY RECOVERED. DURING THE PROCEDURE, UPON THE FIRST PASS AT A SET SPEED OF 17K RPM, THE BURR TANGLED AND GOT CAUGHT ON THE EXISTING STENT STRUTS DISTAL SFA. THE BURR STALLED AND WOULD NOT SPIN. MANIPULATION OF THE DEVICE RELEASE THE BURR AND REMOVE OVER THE WIRE INTACT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT FULLY RECOVERED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926911 ↗