RotaLink™ Advancer H80222782001A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08714729317739), received between Dec 17, 2016 and Sep 8, 2026 — classified as 3 deaths, 2 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Failure to Advance; Output Problem; Intermittent Loss of Power

  It was reported that unstable speed occurred.The stenosed target lesion was located in the Left Anterior Descending artery. A RotaLink Advancer was selected for use. During test outside the patient, everything was normal. However, during the procedure the burr could not be pushed into the guiding catheter, resulting in stalling and stuttering. The device exceeded the set operational speed of 150k rpm as it reached 160k rpm during normal mode. The procedure was completed with another of the same device. There were no patient complications reported post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669980 ↗
• DeathJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient died.It was reported that the patient presented with severe chest pain. A RotaLink Advancer, 1.25 mm RotaLink burr and RotaWire Drive were selected for treatment of the left circumflex (LCX) and left main (LM) arteries. Following rotablation, slow coronary flow was observed. Medications were administered to manage the patient's condition. The patients' blood pressure progressively declined, and the patient experienced cardiac arrest. Direct current defibrillation and cardiopulmonary resuscitation were performed. Despite all efforts, there was no return of spontaneous circulation, no recordable pulse or blood pressure. The patient was declared dead. The official cause of death was slow flow and bradycardia.It was further reported that the patient also presented with shortness of breath, dyspnea and chest heaviness. Injections of adrenaline, atropine, calcium gluconate 10 ml and amiodarone 150 mg were administered during the procedure. Intra-Aortic Balloon Pump (IABP) andTemporary Pacemaker Implantation (TPI) support was also provided. Patient was shifted to the critical care unit and place on mechanical ventilation. The patient experienced ventricula

  Patient problems: Bradycardia; Cardiac Arrest; Diminished Pulse Pressure; Low Blood Pressure/ Hypotension; Reduced Blood Flow; Tachycardia; Ventricular Fibrillation

  MAUDE report 50073952 ↗
• MalfunctionJun 1, 2026Mechanical Problem

  IT WAS REPORTED THAT FAILURE TO LOCK ON WIRE OCCURRED. A ROTABLATOR WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE GUIDEWIRE COULD CONNECT TO THE ADVANCER BUT NOT LOCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AD THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351178 ↗
• MalfunctionMay 12, 2026Decoupling

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 1.50 MM ROTALINK BURR AND ROTALINK ADVANCER W/ TUBULAR DRIVE SHAFT WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER INSERTING INTO THE BODY, THE BURR COULD NOT MOVE IN AND OUT ALONG WITH THE ADVANCER. WHEN PULLED OUT OF THE BODY, IT WAS FOUND THAT THE CONNECTION BETWEEN THE ADVANCER AND THE BURR WAS DISCONNECTED. THE DEVICE MALFUNCTIONED AND THE PROCEDURE WAS CANCELLED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150150 ↗
• MalfunctionApr 13, 2026Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ADVANCER BECAME STUCK. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A ROTABLATOR ROTALINK ADVANCER W/TUBULAR DRIVE SHAFT AND ROTAWIRE-IC WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ADVANCER MALFUNCTIONED DURING ROTATIONAL ATHERECTOMY (RA) AND BECAME STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854096 ↗
• MalfunctionMar 4, 2026Mechanical Problem

  IT WAS REPORTED THAT FAILURE TO LOCK WIRE OCCURRED. THE 90% STENOSED TARGET LESION WITH 10MM IN LENGTH AND 2.67MM IN DIAMETER, WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX. A ROTABLATOR WAS SELECTED FOR USE. DURING INSERTION INTO THE PATIENT'S BODY IN DYNAGLIDE MODE, IT WAS NOTED THAT THE GUIDEWIRE STARTED ROTATING AT THE REAR END OF THE ADVANCER. MULTIPLE SUBSEQUENT TESTS DEMONSTRATED THE SAME ROTATION ISSUE. PER THE PHYSICIAN, GUIDEWIRE MOVEMENT OCCURRED DURING ROTATION WITHOUT INITIATING THE BRAKE DEFEAT INDICATING A MALFUNCTION IN THE MECHANISM WHICH IS DESIGNED TO LOCK THE GUIDEWIRE. THE DEVICE WAS SIMPLY REMOVED AND THE PROCEDURE WAS COMPETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512878 ↗
• MalfunctionDec 22, 2025Mechanical Problem; Nonstandard Device; Material Integrity Problem; Mechanical Problem; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT A BRAKE MALFUNCTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A ROTALINK ADVANCER WAS SELECTED FOR PERCUTANEOUS CORONARY ANGIOPLASTY. DURING THE PROCEDURE, IT WAS NOTED THAT THE ADVANCER COULD NOT ADVANCE BECAUSE THE GUIDEWIRE FAILED TO LOCK PROPERLY IN NORMAL MODE. ADDITIONALLY, THE BLACK BUTTON ON THE GUIDEWIRE CLAMP WAS NON FUNCTIONAL, SHOWING NO MOVEMENT AFTER INITIATING THE BRAKE DEFEAT BUTTON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872904 ↗
• MalfunctionDec 1, 2025Nonstandard Device; Material Integrity Problem; Mechanical Jam; Nonstandard Device; Material Integrity Problem; Mechanical Jam

  IT WAS REPORTED THAT THE BRAKE DEFEAT MALFUNCTIONED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTALINK ADVANCER WITH TUBULAR DRIVE SHAFT WAS SELECTED FOR TREATMENT. DURING PREPARATION, IN NORMAL MODE, IT WAS NOTED THAT THE BRAKE DEFEAT MALFUNCTIONED AND THE DEVICE DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686482 ↗
• MalfunctionOct 16, 2025Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. A ROTALINK ADVANCER W/TUBULAR DRIVE SHAFT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK. THE PHYSICIAN URGENTLY CUT OFF THE BURR AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23315767 ↗
• MalfunctionSep 3, 2025Mechanical Problem; Nonstandard Device; Noise, Audible; Mechanical Problem; Nonstandard Device; Noise, Audible

  IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT BE FIXED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN TRUNK. A ROTALINK ADVANCER AND A ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE ROTALINK ADVANCER AS NOT COMPATIBLE WITH THE DRIVE GUIDEWIRE. THERE WERE ABNORMAL NOISES AT LOW AND HIGH SPEEDS. MOREOVER, WHEN THE TAIL CLIP WAS PROPERLY CLAMPED, THE GUIDEWIRE COULD NOT BE FIXED, AND THE GUIDEWIRE SYSTEM WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT DURING THE BURR WAS ADVANCED, THE GUIDEWIRE WAS NOT LOCKED NO MATTER ADVANCED OR PULLED BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956406 ↗
• MalfunctionAug 29, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04AUG2025. IT WAS REPORTED THAT THE AUTOMATIC KNOB FELL OFF. A ROTALINK ADVANCER W/TUBULAR DRIVE SHAFT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE AUTOMATIC KNOB FELL OFF AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BRAKE DEFEAT BUTTON WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921444 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Intermittent Loss of Power; Gas/Air Leak; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE ADVANCER WAS LEAKING GAS, RESULTING IN THE COMPLETE SET OF DEVICE COULD NOT BE USED. THE DEVICE WAS REMOVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THE SAME DEVICE UNAVAILABILITY. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894636 ↗
• MalfunctionDec 26, 2024Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT A BRAKE MALFUNCTION OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTALINK ADVANCER AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS DAMAGED AND EJECTED CAUSING THE ADVANCER TO BE SCRAPPED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019932 ↗
• MalfunctionJul 29, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE WIRE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTALINK ADVANCER W/TUBULAR DRIVE SHAFT AND ROTAWIRE WERE SELECTED FOR ROTATIONAL ATHERECTOMY. DURING PREPARATION, THE GUIDEWIRE WAS WOUND TOGETHER WITH THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851080 ↗
• MalfunctionJun 25, 2024Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 75% STENOSED, 18MMX3.5MM TARGET LESION WAS IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTALINK ADVANCER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT START AND STALLED. THE PROCEDURE COULD NOT CONTINUE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610426 ↗
• MalfunctionMay 21, 2024Gas/Air Leak; Intermittent Loss of Power; Gas/Air Leak; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A ROTALINK ADVANCER WAS SELECTED FOR USE. PRIOR TO PROCEDURE, PHYSICIAN INFORMED THAT ADVANCER WAS LEAKING. WHEN SPEED WAS TESTED CONSOLE SHOWED STALL AND PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367176 ↗
• MalfunctionMay 14, 2024Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT POSSIBLE CONTAMINATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTALINK ADVANCER W/TUBULAR DRIVE SHAFT WAS SELECTED FOR CORONARY ANGIOGRAPHY. DURING PREPARATION, AFTER DEVICE WAS CONNECTED, THE BLACK KNOB OF THE ADVANCER COULD NOT MOVE BACK AND FORTH, AND THE PHYSICIAN FELT THAT THERE WAS FOREIGN BODY STUCK IN THE DEVICE WHICH WAS NOT VISIBLE TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AND DISCHARGED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310011 ↗
• MalfunctionNov 1, 2023Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX). A ROTALINK ADVANCER AND A 1.25MM ROTALINK BURR WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR AND THE STEEL WIRE OF THE ADVANCER WERE STUCK TOGETHER AT HIGH SPEED. HOWEVER, AS ANOTHER ADVANCER WAS NOT AVAILABLE, THE PROCEDURE COULD NOT BE CONTINUED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047355 ↗
• MalfunctionSep 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ADVANCER DID NOT MATCH THE EQUIPMENT. THE TARGET LESION WAS IN THE HEART. A ROTALINK ADVANCER WITH TUBULAR DRIVE SHAFT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ADVANCER DID NOT MATCH THE EQUIPMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764991 ↗
• MalfunctionAug 9, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IMPROPER LABELLING OCCURRED. A ROTALINK ADVANCER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT MATCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487043 ↗
• MalfunctionAug 9, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IMPROPER LABELLING OCCURRED. A ROTALINK ADVANCER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT MATCH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487042 ↗
• MalfunctionAug 7, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. A ROTALINK ADVANCER WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT MATCH THE LABEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475040 ↗
• MalfunctionJan 23, 2023Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT FLUID LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A ROTALINK ADVANCER W/TUBULAR DRIVE SHAFT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS LEAKING AIR AND WATER AND WAS UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225485 ↗
• MalfunctionOct 11, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A ROTALINK ADVANCER WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE PHYSICIAN WAS CONNECTING THE DEVICE TO NITROGEN, THE ADVANCER WAS FOUND LEAKING. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND THE PATIENT WAS SEDATED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581039 ↗
• MalfunctionOct 6, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A ROTALINK ADVANCER WITH TUBULAR DRIVE SHAFT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS DAMAGED ALONG WITH THE BURR AND DUE TO THIS EVENT THE PROCEDURE WAS CANCELLED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552258 ↗

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