RotaWire™ Elite and wireClip™ Torquer H802223300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729862277), received between Jul 10, 2018 and Jul 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 18, 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.

• MalfunctionJul 10, 2018Material Separation; Material Separation

  SAME CASE AS: MDR ID: 2134265-2018-06425. IT WAS REPORTED THAT THE WIRE BROKE OFF IN FRONT OF THE BURR. A ROTALINK¿ PLUS AND A ROTAWIRE FLOPPY WIRE WERE SELECTED FOR USE FOR A PATIENT PROCEDURE. THE WIRE WAS PLACED INSIDE OF THE PATIENT. THEN THE BURR WAS TESTED OUTSIDE OF THE PATIENT OVER THE ROTAWIRE. WHILE TESTING THE ROTATIONAL SPEED OF 170RPM, THE FLOPPY WIRE THAT WAS DISTAL TO THE TIP OF THE BURR SIMPLY BROKE OFF. THE PORTION OF THE FRACTURED WIRE, AND THE BURR, WERE LOCATED OUTSIDE OF THE PATIENT'S BODY. THEREFORE THE DISTAL PORTION OF THE WIRE THAT WAS INSIDE OF THE PATIENT WAS SIMPLY REMOVED. A NEW WIRE AND ROTALINK PLUS DEVICE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673874 ↗

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-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• 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