Magic Torque™ M001465920Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729741428), received between Mar 21, 2019 and Jan 10, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 035/260 (BX/3) MAGIC TORQUE GUIDEWIRE WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE TIP WAS BROKEN. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134002 ↗
• MalfunctionNov 9, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD) AND UNDERWENT PERIPHERAL ANGIOGRAM. A GW/035/260 MAGIC TORQUE GUIDEWIRE WAS SELECTED FOR USED. HOWEVER, DURING THE PREPARATION, THE FLOPPY TIP WAS NOTICED TO BE STRETCHED UPON REMOVAL FROM THE COIL, AND THE INNER COIL OF THE WIRE SEEMED TO BE DETACHED FROM THE TIP. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765074 ↗
• MalfunctionNov 2, 2022Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE UNRAVELED. A 035/260 (BX/3) MAGIC TORQUE GUIDEWIRE WAS ADVANCED INTO THE LESION. HOWEVER, THE TIP OF THE GUIDEWIRE UNRAVELED WHILE INSIDE THE PATIENT. IT WAS NOTED THAT THIS ALSO HAPPENED IN A SEPARATE CASE USING ANOTHER OF SAME DEVICE. IN BOTH CASES, THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH GOOD BLOOD FLOW. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715018 ↗
• MalfunctionNov 2, 2022Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-OCT-2022. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE UNRAVELED. A 035/260 (BX/3) MAGIC TORQUE GUIDEWIRE WAS ADVANCED INTO THE LESION. HOWEVER, THE TIP OF THE GUIDEWIRE UNRAVELED WHILE INSIDE THE PATIENT. IT WAS NOTED THAT THIS ALSO HAPPENED IN A SEPARATE CASE USING ANOTHER OF SAME DEVICE. IN BOTH CASES, THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH GOOD BLOOD FLOW. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715017 ↗
• MalfunctionJan 28, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDEWIRE'S COATING HAS PEELED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE COMMON/EXTERNAL ILIAC VEIN. A 035/260 (BX/3) MAGIC TORQUE GUIDEWIRE WAS USED. HOWEVER, AFTER THE GUIDEWIRE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTICED THAT THE COATING WAS PEELING OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244438 ↗
• MalfunctionAug 9, 2019Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE TIP SHEARED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 035/260 MAGIC TORQUE GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE TIP WAS SHEARED. THE TIP WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAGIC TORQUE GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879175 ↗
• MalfunctionAug 9, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE WIRE FRACTURED. A GW/035/260 MAGIC TORQUE GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE WIRE SHEARED. THE WIRE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT ABOUT 85-90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THERE WAS NO COATING LEFT INSIDE THE PATIENT'S BODY. THE PHYSICIAN NOTICED THE SHEARING OF THE DEVICE RIGHT AFTER IT WAS NORMALLY REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879140 ↗
• MalfunctionMar 21, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE INNOVA DELIVERY SYSTEM WAS STUCK ON THE WIRE. A MAGIC TORQUE GUIDEWIRE AND A 7X150X130 INNOVA VASCULAR STENT WERE SELECTED FOR A STENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE INNOVA DEVICE. THE INNOVA STENT WAS DEPLOYED SAFELY INTO THE PATIENT. THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AND BECAME STUCK ON THE MAGIC TORQUE GUIDEWIRE. EVERYTHING WAS REMOVED TOGETHER. THE PHYSICIAN LOST WIRE POSITION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441644 ↗