RotaWire Drive and wireClip TorquerRecalls & reported problems across all models

We found 2 models of RotaWire Drive and wireClip Torquer by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 143 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2024 and Sep 15, 2026 — classified as 3 deaths, 39 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (55 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

RotaWire Drive and wireClip Torquer recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 8, 2022Class IIOpen, Classified

   Pouch seals may be open, compromising sterility.

   Z-0916-2022 · Root cause: Process control · Recall details · FDA record ↗

2. Mar 8, 2022Class IIOpen, Classified

   Pouch seals may be open, compromising sterility.

   Z-0915-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported RotaWire Drive and wireClip Torquer problems

RotaWire Drive and wireClip Torquer models

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

• RotaWire™ Drive and wireClip™ Torquer H74939462001

  CATHETER, CORONARY, ATHERECTOMY
  1 recall3 deaths117 reports
• RotaWire™ Drive and wireClip™ Torquer H74939463001

  CATHETER, CORONARY, ATHERECTOMY
  1 recall26 reports

Recent RotaWire Drive and wireClip Torquer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• 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 50773482 ↗
• InjurySep 14, 2026Detachment of Device or Device Component; Difficult to Advance

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 50763664 ↗
• InjurySep 11, 2026Detachment of Device or Device Component

  It was reported that the wire detached and a perforation occurred requiring additional surgery.The 15mm long and 95% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery with a vessel diameter of 3.0 mm. A 1.25mm Rotapro and Rotawire Drive were selected for use. During the procedure, difficulty crossing the lesion was experienced. Seventeen ablations were performed at a set speed of 190,000 rpm for 15 seconds each. The physician noted reductions in speed ranging from 2,000 to 10,000 rpm during ablation. A perforation was observed on the opposite side of the calcified nodule and upon withdrawal of the devices it was noted that the RotaWire had separated a few centimeters proximal to the radiopaque marker. It was considered possible that the separation was due to burr contact. Bypass grafting of the proximal LAD was performed to treat the perforation. No device fragments were left inside the body. Following surgery, the patient was weaned from mechanical ventilation, resumed oral intake, and is currently undergoing rehabilitation.

  Patient problems: Perforation

  MAUDE report 50735310 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  It was reported that a distal tip detachment occurred.The target lesion was located in the severely calcified artery. A ROTAWIRE Drive was selected for use. During the procedure, it was noted that a portion of the radiopaque marker area appeared to be missing and was described as an area that was not a radiopaque marker. The device was completely removed from the patient without any issues. 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 50692012 ↗
• MalfunctionSep 8, 2026Nonstandard Device; Deformation Due to Compressive Stress

  Reportable based on device analysis completed on 13AUG2026.It was reported that the wire was kinked.A Rotawire Drive was selected for use. During unpacking, it was noted that the wire was kinked. A second wire was opened and the same thing occurred. A third wire with a different lot number was able to complete the procedure. There were no patient complications.However, device analysis revealed that the spring tip was detached and did not return for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674414 ↗
• MalfunctionSep 8, 2026Entrapment of Device

  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 50672436 ↗
• InjurySep 8, 2026Detachment of Device or Device Component; Difficult to Advance

  It was reported that a detachment occurred resulting in a retained device fragment. The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified circumflex (Cx) artery. A 1.25mm Rotapro and a RotaWire Drive were selected for use. During the procedure, the wire was placed across the mid Cx vessel but could not be delivered distally. Ablation was performed at 172,000rpm and the burr successfully crossed the calcified portion of the lesion. Dynaglide mode was then activated to retract the burr from the vessel. During removal, the distal tip of the RotaWire separated due to burr contact with the distal portion of the wire. The burr and proximal portion of the RotaWire were successfully removed from the patient; however, a short distal wire fragment remained within the vessel. Echo was performed and no pericardial effusion was found. A stent was placed over the wire fragment anchoring it to the vessel wall. The procedure was completed and the patient was stable post procedure.It was further reported that no attempts were performed to retrieve the fragment and that the procedure was completed with the original device.

  Patient problems: Foreign Body In Patient

  MAUDE report 50671211 ↗
• InjurySep 2, 2026Difficult to Remove; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568645 ↗
• InjurySep 2, 2026Detachment of Device or Device Component; Difficult to Advance

  It was reported that guidewire detached. The patient presented with a chronic total occlusion in the right coronary artery. A Rotawire Drive was selected for use. During procedure, after the guidewire was successfully advanced, the device could not be passed through. Following standard protocol, the rotational atherectomy system was deployed without a guidewire, and treatment was performed using a 1.25 mm burr. The Rotawire was found to have fractured. A post-procedure measurement of the involved length and CT scan indicated that the wire had fractured within the coronary artery. Physician recommended a surgical bypass followed by repeat percutaneous intervention, but the patient refused and requested conservative treatment. The patient currently has no symptoms and has been discharged.

  Patient problems: Foreign Body In Patient

  MAUDE report 50568430 ↗
• MalfunctionSep 1, 2026Entrapment of Device

  It was reported that the burr was stuck on the wire.A 1.75mm Rotapro and Rotawire Drive were selected for use. During the procedure, the wire and the burr got stuck. The burr was removed together with the wire. The procedure was completed with another of same device. There were no patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546938 ↗
• MalfunctionAug 20, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358885 ↗
• MalfunctionAug 19, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333759 ↗
• 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 50308202 ↗
• MalfunctionAug 18, 2026Difficult to Remove; Unraveled Material; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291913 ↗
• MalfunctionAug 4, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50130991 ↗

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