Telescope™ TELE7FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000156978), received between Dec 8, 2021 and Nov 22, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionNov 22, 2024Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG) AND A DEVICE DETACHMENT OCCURRED. IT WAS STATED THAT DURING ADVANCEMENT THROUGH THE GUIDE THE TELESCOPE BROKE. THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER AS IT WAS STILL CONNECTED. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. THE PATIENT IS ALIVE WITHNO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757474 ↗
• InjuryApr 4, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 7F TELESCOPE GUIDE EXTENSION CATHETER DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE SHAFT DETACHED AT THE ENTRY PORT DURING DELIVERY TO/AT THE LESION. THE DETACHED FRAGMENT WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040757 ↗
• MalfunctionDec 8, 2021Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE A TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A MODERATELY TORTUOUS, NON CALCIFIED LESION WITH 90% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT NOTED USED DURING INSERTION. IT WAS REPORTED THAT WHEN ATTEMPTING TO ADVANCE THE STENT THROUGH THE TELESCOPE GUIDE EXTENSION CATHETER, RESISTANCE WAS FELT. BOTH THE TELESCOPE AND STENT WERE REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE PROXIMAL PORTION OF THE TELESCOPE GUIDE EXTENSION CATHETER WAS SEPARATED FROM THE WIRE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960291 ↗