Peripheral ROTAPRO™ H749395141250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191506007119), received between Feb 5, 2025 and Oct 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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 16, 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.

• MalfunctionOct 3, 2025Entrapment of Device; Difficult to Remove; Failure to Advance; Intermittent Loss of Power; Entrapment of Device; Difficult to Remove; Failure to Advance; Intermittent Loss of Power

  IT WAS REPORTED THAT A BURR AND WIRE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PROXIMAL TO DISTAL ANTERIOR TIBIAL ARTERY (ATA). A 1.25 MM ROTAPRO-PI AND PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE IN ACCORDANCE WITH STANDARD ATHERECTOMY INDICATIONS. BURR ADVANCEMENT WAS PERFORMED USING A PECKING MOTION APPROXIMATELY 75% OF THE TIME. THE BURR WAS USED CLOSE TO THE ORIGIN OF THE ATA AND TRAVELED DISTALLY TOWARD THE PEDAL ARTERIES. MIDWAY THROUGH THE ATA, THE BURR BEGAN TO STALL, INCLUDING DURING DYNAGLIDE MODE. ADVANCEMENT BECAME DIFFICULT AT THE MIDPOINT OF THE LESION. IT WAS OBSERVED THAT THE GUIDEWIRE WAS NOT FREELY MOVING WITHIN THE VESSEL AND WAS MOVING TOGETHER WITH THE BURR, INDICATING THE BURR HAD BECOME STUCK ON THE WIRE. MULTIPLE ATTEMPTS WERE MADE TO DISLODGE THE BURR USING BOTH NORMAL AND DYNAGLIDE MODES, BUT THESE WERE UNSUCCESSFUL. THE PHYSICIAN ELECTED TO REMOVE THE ROTAPRO BURR; HOWEVER, IT COULD NOT BE EXTRACTED INDEPENDENTLY OF THE WIRE. CONSEQUENTLY, BOTH THE BURR AND GUIDEWIRE WERE REMOVED TOGETHER AS A SINGLE UNIT. POST-REMOVAL, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214101 ↗
• MalfunctionFeb 5, 2025Device Damaged by Another Device; Output Problem; Device Damaged by Another Device; Output Problem

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED, AND MANIPULATION WAS REQUIRED TO REMOVE IT FROM THE BODY. A 1.25MM PERIPHERAL INTERVENTION ROTAPRO WAS SELECTED FOR USE. DURING PROCEDURE FOR TEST PERIOD, IT WAS NOTED THAT THE DEVICE WAS SEVERED OUTSIDE THE BODY BUT HAD TO BE MANIPULATED TO REMOVE IT FROM THE BODY. PHYSICIAN REGAINED WIRE ACCESS WITH A DIFFERENT WIRE BEFORE EXCHANGING IT FOR A NEW EXTRA SUPPORT ROTAWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313745 ↗