ROTAPRO™ H749394672250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729999614), received between Mar 3, 2025 and Jul 31, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Nonstandard Device; Difficult to Remove; Material Separation; Intermittent Loss of Power

  It was reported that the burr detached.The 90% stenosed target lesion was located in the tortuous and calcified mid to distal right coronary artery. A 2.25mm Rotapro was selected for use. During the procedure, it was noted that a Rotalink separated between the burr and the drive shaft. During removal, resistance was encountered. The fragments were successfully retrieved using a gooseneck snare, and no fragments remained inside the patient's body following the procedure. Per the physician this event occurred due to possible device deterioration resulting from repeated ablation attempts in a severely tortuous vessel, with repeated stall indications being displayed. The procedure was completed with a different device. There were no patient complications, and the patient was in good condition after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104976 ↗
• MalfunctionApr 30, 2026Entrapment of Device

  IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT BURR ENTRAPMENT OCCURRED. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF ROTATIONAL ATHERECTOMY FOR THE TREATMENT OF STENT DEFORMATION ASSOCIATED WITH CALCIFIED PLAQUES. 13 CONSECUTIVE PATIENTS PRESENTING WITH ANGINA PECTORIS SECONDARY TO STENT DEFORMATION CAUSED BY SEVERE CALCIFICATION WERE TREATED BETWEEN DECEMBER 2010 AND DECEMBER 2023. ROTATIONAL ATHERECTOMY WAS PERFORMED TO ABLATE BOTH THE DEFORMED STENT STRUTS AND THE UNDERLYING CALCIFIED PLAQUES. ALL PATIENTS RECEIVED ASPIRIN (100 MG), TICLOPIDINE HYDROCHLORIDE (200 MG), CLOPIDOGREL BISULFATE (75 MG), OR PRASUGREL HYDROCHLORIDE (3.75 MG) ORALLY. A 7F OR 8F ARTERIAL SHEATH WAS USED IN THE PERCUTANEOUS TRANSLUMINAL CORONARY ROTATIONAL ATHERECTOMY (PTCRA) PROCEDURE. A TEMPORARY PACEMAKER WAS INSERTED TRANSFEMORALLY THROUGH A 6F SHEATH. A 0.009-INCH ROTAWIRE EXTRA SUPPORT GUIDEWIRE WITH A 0.014-INCH TIP (BOSTON SCIENTIFIC (BSC) WAS PASSED THROUGH THE LESION TO THE DISTAL CORONARY ARTERY. IN THE FIRST STEP, STENTABLATION WAS PERFORMED, IN WHICH A BURR OF THE OPTIMAL SIZE WAS USED TO ABLATE THE DEFORMED STENT STRUTS. IN THE SECOND STEP, THE BURR SIZE WAS INCREASED AS NEEDED TO AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045401 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT POST PROCEDURE MYOCARDIAL INFARCTION OCCURRED. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF ROTATIONAL ATHERECTOMY FOR THE TREATMENT OF STENT DEFORMATION ASSOCIATED WITH CALCIFIED PLAQUES. 13 CONSECUTIVE PATIENTS PRESENTING WITH ANGINA PECTORIS SECONDARY TO STENT DEFORMATION CAUSED BY SEVERE CALCIFICATION WERE TREATED BETWEEN DECEMBER 2010 AND DECEMBER 2023. ROTATIONAL ATHERECTOMY WAS PERFORMED TO ABLATE BOTH THE DEFORMED STENT STRUTS AND THE UNDERLYING CALCIFIED PLAQUES. ALL PATIENTS RECEIVED ASPIRIN (100 MG), TICLOPIDINE HYDROCHLORIDE (200 MG), CLOPIDOGREL BISULFATE (75 MG), OR PRASUGREL HYDROCHLORIDE (3.75 MG) ORALLY. A 7F OR 8F ARTERIAL SHEATH WAS USED IN THE PERCUTANEOUS TRANSLUMINAL CORONARY ROTATIONAL ATHERECTOMY (PTCRA) PROCEDURE. A TEMPORARY PACEMAKER WAS INSERTED TRANSFEMORALLY THROUGH A 6F SHEATH. A 0.009-INCH ROTAWIRE EXTRA SUPPORT GUIDEWIRE WITH A 0.014-INCH TIP (BOSTON SCIENTIFIC (BSC) WAS PASSED THROUGH THE LESION TO THE DISTAL CORONARY ARTERY. IN THE FIRST STEP, STENTABLATION WAS PERFORMED, IN WHICH A BURR OF THE OPTIMAL SIZE WAS USED TO ABLATE THE DEFORMED STENT STRUTS. IN THE SECOND STEP, THE BURR SIZE WAS INCR

  Patient problems: Myocardial Infarction

  MAUDE report 25045399 ↗
• MalfunctionApr 30, 2026Entrapment of Device

  IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT DEVICE ENTRAPMENT OCCURRED. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF ROTATIONAL ATHERECTOMY FOR THE TREATMENT OF STENT DEFORMATION ASSOCIATED WITH CALCIFIED PLAQUES. 13 CONSECUTIVE PATIENTS PRESENTING WITH ANGINA PECTORIS SECONDARY TO STENT DEFORMATION CAUSED BY SEVERE CALCIFICATION WERE TREATED BETWEEN DECEMBER 2010 AND DECEMBER 2023. ROTATIONAL ATHERECTOMY WAS PERFORMED TO ABLATE BOTH THE DEFORMED STENT STRUTS AND THE UNDERLYING CALCIFIED PLAQUES. ALL PATIENTS RECEIVED ASPIRIN (100 MG), TICLOPIDINE HYDROCHLORIDE (200 MG), CLOPIDOGREL BISULFATE (75 MG), OR PRASUGREL HYDROCHLORIDE (3.75 MG) ORALLY. A 7F OR 8F ARTERIAL SHEATH WAS USED IN THE PERCUTANEOUS TRANSLUMINAL CORONARY ROTATIONAL ATHERECTOMY (PTCRA) PROCEDURE. A TEMPORARY PACEMAKER WAS INSERTED TRANSFEMORALLY THROUGH A 6F SHEATH. A 0.009-INCH ROTAWIRE EXTRA SUPPORT GUIDEWIRE WITH A 0.014-INCH TIP (BOSTON SCIENTIFIC (BSC) WAS PASSED THROUGH THE LESION TO THE DISTAL CORONARY ARTERY. IN THE FIRST STEP, STENTABLATION WAS PERFORMED, IN WHICH A BURR OF THE OPTIMAL SIZE WAS USED TO ABLATE THE DEFORMED STENT STRUTS. IN THE SECOND STEP, THE BURR SIZE WAS INCREASED AS NEEDED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045382 ↗
• InjuryMar 3, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK IN LESION. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY ANGULATED AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 2.25MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR BECAME STUCK IN THE LESION. SEVERAL MANEUVERS WERE DONE IN AN ATTEMPT TO FREE THE BURR. FIRST, DYNAGLIDE WAS USED WITH TRACTION UNSUCCESSFULLY. NEXT, A SECOND WIRE WAS ADVANCED PAST THE BURR AND A BALLOON WAS INFLATED NEXT TO THE BURR FOLLOWED BY TRACTION, WHICH WAS ALSO UNSUCCESSFUL. ULTIMATELY, THE BURR SHAFT WAS CUT, AND A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER WAS ADVANCED TO THE BURR. THE BURR WAS COMPLETELY REMOVED FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND WAS PROLONGED RESULTING IN EXCESS OF 6 GY OF RADIATION. THE PATIENT CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21504814 ↗

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