RotaLink™ Burr H802227680150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729185826), received between Sep 16, 2021 and Oct 6, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE BURR DETACHED. A 2.15MM ROTALINK BURR WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE BURR DETACHED WHEN UNPACKED AND COULD NOT BE USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583409 ↗
• MalfunctionSep 29, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.15MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, 3MM PAST THE FIRST BEND IN THE VESSEL, IT WAS NOTED THAT THE BURR BECAME STUCK IN THE LESION. THE DEVICE WAS DIRECTLY REMOVED FROM THE PATIENT'S BODY WITH SLIGHT RESISTANCE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550970 ↗
• MalfunctionSep 16, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.15MM ROTALINK BURR WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK IN THE LESION. THE DEVICE WAS SIMPLY PULLED OUT WITH AN EXTENSION CATHETER SUPPORT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12483814 ↗

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-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
• 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