ROTAPRO™ H749394671500Recalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 08714729999577), received between Jun 17, 2021 and Sep 26, 2026 — classified as 7 deaths, 39 injuries, 159 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (78 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 205 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2026Entrapment of Device; Material Separation; Output Problem; Intermittent Loss of Power

  Patient problems: Vascular Dissection

  MAUDE report 50909428 ↗
• MalfunctionSep 24, 2026Mechanical Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891313 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848310 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak; Nonstandard Device

  Reportable based on device analysis completed on 28Aug2026.It was reported that a fluid leak occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery. A 1.50mm RotaPro was selected for use. During the procedure while outside the patient, when performing air removal on the advancer, near the tube where the Rota cocktail flows, Rota solution was leaking out. The procedure was completed with another of the same device and no patient complications were reported. However, device analysis revealed the sheath was torn at 20.6cm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820255 ↗
• MalfunctionSep 15, 2026Entrapment of Device; Intermittent Loss of Power

  It was reported that the burr got stuck in the lesion.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery. A 1.50mm RotaPro was selected for use. During the procedure, it was noted that the burr became stuck due to challenging and complex anatomy. The device was continuously stalling. The device was removed and another of the same device was used to complete the procedure successfully. There were no complications reported and the patient is stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774728 ↗
• MalfunctionSep 15, 2026Output Problem

  It was reported that unstable rotation speed occurred. A 1.50mm Rotapro was selected for use. During procedure, it was noted that the rotation speed was unstable, it increased and decreased. The procedure was completed with a different device. There were no patient complications, and the patient condition was stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774392 ↗
• MalfunctionSep 15, 2026Output Problem

  It was reported that unstable rotation speed occurred.A 1.50mm Rotapro was selected for use. During procedure, it was noted that the rotation speed was unstable, it increased and decreased. The procedure was completed with a different device. There were no patient complications, and the patient condition was stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774391 ↗
• MalfunctionSep 15, 2026Material Split, Cut or Torn

  It was reported that the protective sleeve was fractured.A 1.50mm Rotapro was selected for use. During procedure, it was noted that the protective sleeve of the device was fractured. The procedure was completed with another of the same device. There were no patient complications, and patient condition was stable following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773487 ↗
• MalfunctionSep 15, 2026Entrapment of Device

  It was reported that the burr and wire became stuck.A 1.50mm Rotapro and a RotaWire Drive were selected for use. During the procedure, it was noted that the burr and wire became stuck. The Rotawire and burr were removed together from the patient as a single unit. The procedure was completed with another burr and another wire. 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 50773486 ↗
• MalfunctionSep 11, 2026Device Contamination with Chemical or Other Material; Output Problem; Noise, Audible; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739334 ↗
• MalfunctionSep 10, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722377 ↗
• InjurySep 9, 2026Failure to Advance; Device Damaged by Another Device

  It was reported during a conference that device detachment and patient complications occurred requiring additional intervention.The patient presented with ischemic heart disease. The chronic total occlusion (CTO) target lesion was located in the calcified mid left anterior descending (LAD) artery. The lesion was crossed using wire escalation technique and a Rotawire was exchanged and inserted into the distal LAD. A 1.50 mm RotaPro was introduced to ablate the calcified CTO, however after a long time rotablating, the lesion could not be crossed. The physician tried at high speed - 200k RPM and on advancement the burr continued in a straight line (not in the pathway of the Rotawire). The Rotawire had snapped at the point of the calcified lesion and the Rotaburr advanced without wire support and perforated the LAD wall and went into the pericardial sac. The Rotawire and Rotaburr were removed, and pericaridocentesis was performed. The perforation was treated with a covered stent, and the distal vessel was embolised using a coil. The patient was stable after the procedure.

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 50682512 ↗
• MalfunctionSep 8, 2026Entrapment of Device; Difficult to Remove; Difficult to Advance

  It was reported that the burr became stuck on the guidewire.The 90% stenosed target lesion was located in the severely calcified left anterior descending (LAD) artery. A 1.50mm RotaPro and ROTAWIRE Drive were selected for use. The ROTAWIRE was crossed into the LAD and placed across the lesion. When the burr was advanced, it failed to advance on the wire beyond a certain point just proximal to the non-Boston Scientific guide catheter. When the physician attempted to withdraw the catheter, it would not move. The wire was hydrated, and the RotaPro was pulled with force; but could not be withdrawn. Due to the inability to either withdraw or advance the burr, the entire assembly was withdrawn. The procedure was completed using alternate devices. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672435 ↗
• InjurySep 8, 2026Entrapment of Device; Material Separation; Intermittent Loss of Power

  It was reported that the burr became stuck, detached and was retained in the artery. The 80-90% stenosed target lesion was located in the mildly tortuous and severely calcified ostial circumflex and left main coronary artery. A 1.50mm Rotapro and a Rotawire were selected for use. During the procedure, it was noted that the burr stalled, became stuck in the lesion and detached. The burr could not be removed from the distal wire. Attempts to retrieve the detached burr via snare were not successful. Th burr was stented in place and the procedure was completed. There were no further patient complications, and the patient was stable after the procedure.

  Patient problems: Foreign Body In Patient

  MAUDE report 50670668 ↗
• MalfunctionSep 3, 2026Nonstandard Device; Device Remains Activated; Fitting Problem; Difficult or Delayed Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599765 ↗
• InjurySep 3, 2026Entrapment of Device; Nonstandard Device; Difficult to Remove; Material Separation; Intermittent Loss of Power

  It was reported that the device detached requiring additional surgery. The 90% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery (RCA). A 1.50 mm RotaPro and RotaWire were selected for treatment. Dynaglide mode was initiated and the device was advanced just proximal to the lesion. After several ablations, the burr became stuck in the lesion and the device stalled. The device remained stuck in the lesion and in a stalled state despite many attempts to free the burr by initiating rotation in Dynaglide mode. The advancer was then pulled, resulting in separation of the burr. After removal of the device from the body, it was confirmed that the RotaWire had also separated approximately 30 cm from the tip within the guide catheter. The fragment migrated to the aorta and could not be retrieved via snare. Retrieval of the burr was attempted by inserting a trapping balloon and pulling the guide catheter, but the device remained stuck in the lesion. An additional guide catheter was inserted via an alternate vascular access site and a guidewire was then advanced to the lesion using the double-guide technique. Dilation with a small diameter

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50588247 ↗
• MalfunctionSep 2, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571733 ↗
• InjurySep 2, 2026Break; Entrapment of Device; Difficult to Remove; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569996 ↗
• MalfunctionAug 18, 2026Entrapment of Device

  It was reported that a burr stuck on guidewire issue occurred.A 1.50mm ROTAPRO was selected for treatment of the target lesion that was located in the right coronary artery (RCA) and was moderately calcified and mildly tortuous. During the procedure, while adjusting the rotation speed, it was noted that the drill head broke off outside of the patient. A new 1.50mm ROTAPRO was selected for treatment to continue the procedure. After several runs, it was noted that the burr could no longer move over the wire. It was attempted to move the knob several times; however, the issue did not resolve. The ROTAPRO and wire were completely removed together, and the procedure was completed as planned with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308208 ↗
• MalfunctionAug 11, 2026Mechanical Problem; Nonstandard Device; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216454 ↗
• MalfunctionAug 4, 2026Output Problem; Material Split, Cut or Torn; Intermittent Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132409 ↗
• MalfunctionAug 4, 2026Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130940 ↗
• MalfunctionAug 3, 2026Fluid/Blood Leak; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115649 ↗
• InjuryAug 3, 2026Entrapment of Device

  It was reported that the burr stuck in lesion occurred, and wire was transected requiring additional surgery.The target lesion was located in the left anterior descending artery. A 1.50mm Rotapro and Rotawire was selected for use. During procedure, the burr was lodged/stuck in the coronary left anterior descending artery. A surgery and triple bypass procedure was performed, and a portion of wire was reportedly transected in the ostium of the artery with the head and distal burr portion unable to be safely removed. The surgery to remove device was unsuccessful. There were no patient complications.

  Patient problems: Foreign Body In Patient

  MAUDE report 50115427 ↗
• MalfunctionJul 31, 2026Nonstandard Device; Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50102960 ↗

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