RotaLink™ Plus H749236310030Recalls & reported problems

Summary

The FDA's MAUDE database contains 381 adverse event reports that list this exact device (DI 08714729228363), received between Nov 16, 2016 and Sep 25, 2026 — classified as 12 deaths, 67 injuries, 302 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (126 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 25 most recent of 381 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Nonstandard Device; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903109 ↗
• MalfunctionSep 24, 2026Nonstandard Device; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891315 ↗
• InjurySep 9, 2026Entrapment of Device

  Patient problems: Cardiac Arrest

  MAUDE report 50698115 ↗
• MalfunctionAug 28, 2026Difficult to Remove; Failure to Advance; Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50494995 ↗
• InjuryAug 19, 2026Entrapment of Device; Mechanical Jam; Output Problem

  It was reported that the burr was stuck requiring additional intervention. The 90% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery. A 1.50mm Rotablator RotaLink Plus was selected for use. During the procedure, the device was operated at a set rotational speed of 180K rpm, with a maximum observed speed of 190K rpm. Significant resistance between the burr and guidewire was experienced. The burr became stuck within the lesion, and the deceleration indicator appeared. Due to the burr entrapment, the catheter and guidewire were removed together as one unit, with balloon dilatation utilized to facilitate device retrieval. The procedure was completed with another of the same device. There were no further patient complications, and the patient was in good condition after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326183 ↗
• MalfunctionJul 22, 2026Contamination; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906871 ↗
• MalfunctionJul 16, 2026Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE BURR GOT STUCK IN THE LESION. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, INSIDE THE PATIENT, WHEN THE BURR ROTATED AT HIGH SPEED TO PUSH CROSS THE SIGNIFICANT CALCIFIED PLAQUE, THE SPEED DECREASED AND THE BURR WAS BITTEN BY THE CALCIFIED LESION RESULTING IN MECHANICAL STUTTER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847612 ↗
• MalfunctionJun 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A FLUID LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY HEART. A ROTABLATOR PLUS WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE BURR WAS LEAKING LIQUID AFTER IT WAS CONNECTED TO THE LIQUID. THE ROTATIONAL ATHERECTOMY COULD NOT BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379762 ↗
• MalfunctionApr 27, 2026Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.50MM ROTABLATOR ROTALINK PLUS AND ROTAWIRE-IC WERE SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN PREPARED FOR ROTATIONAL ABLATION AND USED THE GUIDEWIRE FOR CALCIFICATION TREATMENT. AFTER EXCHANGING THE ROTATIONAL ABLATION GUIDEWIRE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE GUIDEWIRE WAS CONNECTED TO THE BURR. THE GUIDEWIRE CROSSED THE TAIL END OF THE BURR AND WAS SLOWLY INSERTED INTO THE BLOOD VESSEL TO APPROACH THE CALCIFICATION AREA. HOWEVER, DURING THE ROTATIONAL ABLATION PROCESS, IT WAS FOUND THAT THE GUIDEWIRE WAS STUCK TO THE BURR AND COULD NOT BE PUSHED FORWARD OR BACKWARD. AFTER TRYING SEVERAL TIMES, IT WAS NOT POSSIBLE TO PUSH IT. THEREFORE, THE BURR AND GUIDEWIRE WERE REPLACED, AND THE PROCEDURE WAS COMPLETED USING 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 25001709 ↗
• MalfunctionFeb 26, 2026Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. A 1.50MM ROTABLATOR PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT BE WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE BURR AND WIRE WERE STUCK TOGETHER AND REMOVED AS ONE UNIT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457258 ↗
• MalfunctionFeb 23, 2026Output Problem

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN TRUNK ARTERY. A 1.50MM ROTABLATOR PLUS WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, INSIDE THE PATIENT, IT WAS NOTED THAT THE DEVICE COULD NOT SWITCH BETWEEN THE HIGH AND LOW SPEED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416516 ↗
• MalfunctionFeb 5, 2026Nonstandard Device; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JAN2026. IT WAS REPORTED THAT DEVICE FAILED TO REACH OPTIMUM SPEED. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, THE ROTA BURR WAS MANUALLY TAKEN TO THE LESION SITE. ROTABLATION HAD BEGUN AND THE SPEED WAS CONSTANTLY DROPPING, EVEN AFTER INCREASING THE SPEED. THE SET ROTATIONAL SPEED WAS 180K RPM AND OBSERVED MAXIMUM ROTATIONAL SPEED WAS LESS THAN 130K RPM. THE PROCEDURE WAS COMPLETED USING ANOTHER ROTALINK PLUS. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DETACHED COIL AT THE BURR END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270087 ↗
• InjuryDec 24, 2025Entrapment of Device; Nonstandard Device; Material Separation; Mechanical Jam; Entrapment of Device; Nonstandard Device; Material Separation; Mechanical Jam

  IT WAS REPORTED THAT THE BURR BECAME STUCK AND DETACHED REQUIRING ADDITIONAL INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE BURR WAS ADVANCED TO THE IN-STENT RESTENOSIS WITH RESISTANCE AND DURING ATTEMPTED ABLATION, THE BURR BECAME STUCK AND DETACHED. RETRIEVAL OF THE BURR WAS ACHIEVED USING OTHER MEDICAL EQUIPMENT AND THE ROTAWIRE. ANOTHER METHOD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889286 ↗
• MalfunctionDec 18, 2025Nonstandard Device; Intermittent Loss of Power; Nonstandard Device; Intermittent Loss of Power

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 24NOV2025. IT WAS REPORTED THAT THE DEVICE KEPT SHOWING STALL. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR COMPLEX PTCA WITH ROTABLATION. DURING THE PROCEDURE, THE DEVICE KEPT SHOWING STALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS IDENTIFIED THE SHEATH WAS TORN, 9.3CM PROXIMAL FROM THE SHEATH'S TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843527 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE MID PART OF THE SHEATH. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A HOLE IN THE MID PART OF THE SHEATH AND THE FLUSH WAS NOT REACHING THE BURR SIDE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686794 ↗
• MalfunctionNov 24, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 1.50MM ROTABLATOR PLUS WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE CATHETER REACHED THE LESION BUT FAILED TO OPERATE BECAUSE GAS WAS NOT DELIVERED. THE PROCEDURE WAS NOT COMPLETED DUE TO SAME DEVICE UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634062 ↗
• MalfunctionNov 22, 2025Failure to Advance; Output Problem; Nonstandard Device; Failure to Advance; Output Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTABLATOR PLUS WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). DURING THE PROCEDURE, IT WAS NOTED THAT THE BURRING PRESSURE DROPPED, AND THE BURR WAS UNABLE TO CROSS THE LESION; THEREFORE, THE PROCEDURE HAD TO BE WITHDRAWN. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625687 ↗
• MalfunctionNov 12, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE BURR AND GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING ARTERY, A 1.50MM ROTABLATOR PLUS AND ROTAWIRE - IC WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATIONAL ATHERECTOMY GUIDEWIRE WAS FRACTURED, RESULTING IN THE SCRAPPING OF THE DEVICE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY, AND THE BURR CAUSED THE GUIDEWIRE TO FRACTURE. THE GUIDEWIRE FRAGMENT WAS NOT REMOVED FROM THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535535 ↗
• MalfunctionOct 23, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.50 MM ROTABLATOR PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, ROTABLATION WAS PERFORMED FOR PLAQUE MODIFICATION. ROTALINK PLUS WAS TAKEN FOR PREPARATION BUT WHILE PERFORMING DRAW TEST ON DYNAGLIDE MODE, BURR DRIVESHAFT DETACHED FROM THE PROTECTIVE SHEATH. THE DEVICE WAS THEN REMOVED FROM THE WIRE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23370364 ↗
• MalfunctionOct 21, 2025Leak/Splash; Output Problem; Leak/Splash; Output Problem

  IT WAS REPORTED THAT A SALINE LEAK OCCURRED IN THE CATHETER. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION PRIOR TO THE PROCEDURE, THE PHYSICIAN WAS TREATING THE PATIENT FOR A ROTABLATION PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) UNDER IMAGE GUIDANCE. AFTER SUCCESSFUL PLACEMENT OF THE ROTAWIRE, A DRAW TEST WAS PERFORMED WHILE ADVANCING THE BURR. DURING THE TEST, A SALINE LEAK WAS OBSERVED BETWEEN THE PROTECTIVE SHEATH OF THE ROTABURR, AND THE BURR SPEED WAS FOUND TO BE INADEQUATE. SHORTLY AFTERWARD, AN ERROR MESSAGE APPEARED ON THE ROTAPRO CONSOLE. CONSIDERING PATIENT SAFETY, THE ATTENDING PHYSICIAN REMOVED THE DEVICE FROM THE ROTAWIRE. THE PROCEDURE WAS THEN COMPLETED USING A ROTAPRO BURR OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353902 ↗
• MalfunctionOct 16, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. IT WAS REPORTED THAT DEVICE WAS CONTAMINATED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316689 ↗
• MalfunctionOct 15, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS LESION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS FELT WHILE TRYING TO NEGOTIATE THE DEVICE THROUGH THE LESION. THE BURR ONLY REACHED SMOOTHLY TILL THE PROXIMAL LESION. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A DETACHED BURR AND COIL AT THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301454 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Fitting Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Fitting Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONNECTOR WAS POOR. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT THE CONNECTOR WAS POOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290062 ↗
• MalfunctionOct 2, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE ADDITIONAL INFORMATION FROM THE RELATED COMPLAINT INVESTIGATION RESULT ON 05SEP2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES OR FAILURE OCCURRED. THE 98% TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.50MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR COMPLEX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, BASED ON THE ADDITIONAL INFORMATION FROM THE RELATED COMPLAINT INVESTIGATION RESULT, IT WAS CONFIRMED THAT THE BURR WAS STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23201390 ↗
• MalfunctionSep 5, 2025Entrapment of Device; Gas/Air Leak; Output Problem; Entrapment of Device; Gas/Air Leak; Output Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE WIRE. A 1.50 MM ROTABLATOR ROTALINK PLUS AND A 330 CM GW (1PK) FLOP ROTAWIRE WERE SELECTED FOR USE. DURING DEVICE PREPARATION AND EXECUTION OF THE DRAW TEST, THE CONSOLE REGISTERED A SUDDEN DROP IN RPM, ACCOMPANIED BY AN AUDIBLE GAS LEAK FROM THE DEVICE. A SECOND TEST WAS PERFORMED, WITH THE SAME GAS LEAK NOTED. WHEN ATTEMPTING TO DISENGAGE THE ROTALINK BURR FROM THE ROTAWIRE, THE BURR BECAME LODGED AND COULD NOT BE SEPARATED. AS A RESULT, BOTH THE BURR AND THE GUIDEWIRE WERE REMOVED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978310 ↗

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