HI-TORQUE EXTRA S'PORT 22235MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648079603), received between Nov 3, 2016 and Jun 29, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment Of 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 18, 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.

• InjuryJun 29, 2021Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  N/A

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12085662 ↗
• InjuryJan 3, 2017Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 014 S'PORT GUIDE WIRE WAS INSERTED INTO THE LESION AND A 2.25X18MM XIENCE ALPINE STENT WAS IMPLANTED PROXIMALLY. THE GUIDE WIRE WAS PULLED BACK AND A 2.25X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. AN ATTEMPT TO ADVANCE THE 2.25X23MM XIENCE ALPINE STENT DISTALLY WAS MADE; HOWEVER, IT COULD NOT CROSS PAST THE 2.25X18MM XIENCE ALPINE STENT. THE 2.25X23MM XIENCE ALPINE SDS WAS REMOVED; HOWEVER, THE GUIDE WIRE BECAME STUCK IN THE STENT. THE GUIDE WIRE SEPARATED AND A MICRO SNARE GOOSENECK RETRIEVAL WIRE WAS USED TO REMOVE THE DISTAL TIP OF THE GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6220412 ↗
• InjuryNov 3, 2016Detachment Of Device Component

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE IN THE ANTERIOR TIBIAL ARTERY, THE TIP OF THE SPORT GUIDE WIRE WAS NOTED TO HAVE SEPARATED. THE TIP WAS EMBEDDED IN A COLLATERAL VESSEL, BUT IT DID NOT IMPACT BLOOD FLOW. TIP EMBOLIZATION WAS NOT A CONCERN AS THE TIP WAS NOTED TO BE STABLE IN THE VESSEL. NO ADDITIONAL INTERVENTION WAS PERFORMED FOR THE TIP DETACHMENT. THE PATIENT DID NOT REPORT SYMPTOMS RELATED TO THIS TIP SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6077842 ↗