RotaLink PlusRecalls & reported problems across all models

We found 6 models of RotaLink Plus by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 854 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2016 and Sep 25, 2026 — classified as 26 deaths, 150 injuries, 678 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (307 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RotaLink Plus problems

RotaLink Plus models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RotaLink™ Plus H749236310030

  CATHETER, CORONARY, ATHERECTOMY
  12 deaths381 reports
• RotaLink™ Plus H749236310020

  CATHETER, CORONARY, ATHERECTOMY
  11 deaths274 reports
• RotaLink™ Plus H749236310040

  CATHETER, CORONARY, ATHERECTOMY
  3 deaths136 reports
• RotaLink™ Plus H749236310050

  CATHETER, CORONARY, ATHERECTOMY
  43 reports
• RotaLink™ Plus H749236310060

  CATHETER, CORONARY, ATHERECTOMY
  11 reports
• RotaLink™ Plus H749236310150

  CATHETER, CORONARY, ATHERECTOMY
  9 reports

Recent RotaLink Plus adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 7, 2026Mechanical Problem

  It was reported that failure to lock on wire occurred. The 90% stenosed, 32 mm long target lesion was located in the moderately tortuous and severely calcified left anterior descending artery with a vessel diameter pf 3.5 mm. A 1.25mm Rotablator Plus and RotaWire were selected for use. During procedure, it was noted that after the burr stopped rotating at a low speed upon reaching 1-2cm from the lesion site, the guide wire moved backward with unknown reasons. The device was replaced. The procedure was completed with another of the same device. There were no patient complications, and the patient condition was stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181030 ↗
• MalfunctionJul 22, 2026Contamination; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906871 ↗
• MalfunctionJul 16, 2026Nonstandard Device; Deformation Due to Compressive Stress; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUN2026. IT WAS REPORTED THAT DEVICE WAS KINKED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE WAS NOTED TO BE KINKED DUE TO ANGULATION WHEN CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25847621 ↗
• 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 ↗
• MalfunctionMay 12, 2026Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT THE BURR GOT DETACHED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR KEEPS COMING OFF AND THERE WAS A DOUBLE-ANGLED SECTION. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150241 ↗
• 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 ↗
• MalfunctionMar 31, 2026Nonstandard Device; Intermittent Loss of Power

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06MAR2026. IT WAS REPORTED THAT THE DEVICE STALLED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 1.25MM ROTABLATOR ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR CONTINUOUSLY STALLED WHEN PRESSING THE FOOT PEDAL DESPITE RUNNING WITH SALINE AND ALL PRESSURES BEING NORMAL FOR THE NITROGEN CYLINDER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BURR WAS DETACHED AND THE FULL LENGTH OF THE COIL WAS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745158 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak; Physical Resistance/Sticking

  IT WAS REPORTED THAT WATER LEAKAGE WAS OBSERVED AT THE MIDDLE OF THE SHAFT. A 1.25MM ROTALINK? PLUS WAS SELECTED FOR TREATMENT OF THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION, WATER LEAKAGE WAS OBSERVED AT THE MIDDLE SECTION OF THE SHAFT INSTEAD OF THE NORMAL DRIP AT THE REAR END OF THE DEVICE. THE GUIDEWIRE CROSSED THE TIP OF THE DEVICE BUT COULD NOT SMOOTHLY EXIT THE TAIL END. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE BURR. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554633 ↗
• DeathMar 2, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 1.25MM ROTABLATOR PLUS AND 330CM ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHILE DOING ROTATIONAL ATHERECTOMY ANGIOPLASTY, THE BURR STUCK AND INDUCED A PERFORATION, WHICH CAUSED THE PATIENT TO EXPIRE.

  Patient problems: Perforation

  MAUDE report 24484630 ↗

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