Magic Torque™ M001465910Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729741411), received between Jun 2, 2022 and Aug 31, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. A 035/180 MAGIC TORQUE GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, WHEN PULLING FROM THE CATHETER, RESISTANCE WAS FELT AND THE GUIDEWIRE UNRAVELED AT THE TIP. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327728 ↗
• MalfunctionAug 8, 2022Stretched; Detachment of Device or Device Component; Material Deformation; Stretched; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT CORE WIRE DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). A 035/180 (BX/1) MAGIC TORQUE GUIDEWIRE WAS SELECTED FOR USE. UPON UNPACKING THE DEVICE, THE WIRE TIP SEEMED TO FEEL 'REALLY FLOPPY' IN THE WORDS OF THE PHYSICIAN. THE PHYSICIAN STATED THAT "IT'S LIKE THE CORE OF THE WIRE AND THE OUTER LAYER OF THE WIRE ARE DISCONNECTED." THE PROCEDURE WAS COMPLETED USING ALTERNATE METHOD OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15184185 ↗
• InjuryJun 2, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE PATIENT EXPERIENCED PAIN AND GUIDEWIRE FRACTURE OCCURRED. PATIENT WAS IN FOR ELECTIVE CARDIAC CATHETERIZATION WITH PRIMARY ACCESS AT THE RADIAL ARTERY. COPIOUS AMOUNTS OF ARTERIAL NITROGLYCERIN WERE ADMINISTERED, HOWEVER, DESPITE THIS THE PHYSICIAN WAS UNABLE TO NAVIGATE A 5FR NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER INTO THE SUBCLAVIAN DUE TO SIGNIFICANT PAIN AND SPASM. SO, THE SITE WAS CHANGED TO A FEMORAL APPROACH. WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE 5FR CATHETER AND A 035/180 MAGIC TORQUE GUIDEWIRE, THE PATIENT HAD SIGNIFICANT PAIN WHICH PROMPTED FURTHER ARTERIAL SPASM. MORE NITROGLYCERIN WAS ADMINISTERED INTRA-ARTERIALLY TO AMELIORATE SPASM, HOWEVER, THE MAGIC TORQUE WIRE WAS PARTIALLY FRACTURED, AND A SMALL AMOUNT OF WIRE WAS LEFT IN THE DISTAL RADIAL ARTERY. COMPRESSION WAS OBTAINED WITH A NON-BSC COMPRESSION DEVICE. PATIENT WAS EVALUATED POST PROCEDURE AND BRISK RADIAL PULSE WITH A SMALL HEMATOMA THAT WAS STABLE, AND THE HAND WAS NEUROVASCULAR INTACT.

  Patient problems: Foreign Body In Patient; Hematoma; Pain; Vasoconstriction

  MAUDE report 14580305 ↗