ROTAPRO™ H749393002250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729893400), received between Mar 25, 2019 and Mar 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

4 other recalls cover devices cleared under the same FDA submission (P900056); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2019Entrapment of Device; Mechanical Problem; Difficult to Remove; Noise, Audible; Entrapment of Device; Mechanical Problem; Difficult to Remove; Noise, Audible

  IT WAS REPORTED THAT DIFFICULTY REMOVING OCCURRED. THE 75 PERCENT STENOSED, 4MM-5MM DIAMETER MODERATELY TORTUOUS AND SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) PROXIMAL TO RIGHT CORONARY ARTERY (RCA) DISTAL WITH A LENGTH OF 50MM. DURING SET UP, THE ROTATION SPEED OF THE 2.25MM ROTAPRO WAS SET TO 180,000 RPM AND THERE WAS NO PROBLEM NOTED. THE BURR WAS INSERTED INTO THE GUIDING CATHETER IN DYNAGLIDE MODE; HOWEVER THE STALL LAMP LIT UP AT THE CURVE PART ON THE PROXIMAL PART OF THE GUIDING CATHETER TIP. THE HOSES WERE RECHECKED AND NO KINKS WERE NOTED. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE BURR USING DYNAGLIDE BUT THE STALL LAMP LIT UP. A SQUEAKING SOUND WAS HEARD, SO THE GUIDING CATHETER WAS REPLACED. AFTER REPLACEMENT, THE BURR WAS INSERTED WITHOUT PROBLEM. ABLATION WAS PERFORMED FROM RCA PROXIMAL TO THE DISTAL OF RCA MID. A TOTAL OF 4 ABLATIONS WERE PERFORMED. THE ROTATION SPEED OF THE 1ST AND 2ND ABLATIONS WERE 170,000 RPM. THE ROTATION SPEED OF THE 3RD AND 4TH ABLATIONS WERE 190,000 RPM. DURATION OF EACH ABLATION WAS 12 SECONDS. ABLATION WAS COMPLETED. DURING REMOVAL, THE BURR BECAME STUCK AT THE CALCIFICATION IN THE RCA PROXIMAL AND IT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449842 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P900056. One submission often covers many models, so check the product and lot details in each record.

• Z-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0211-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator
• Z-0212-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rota