PT²™ H7493893104J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729471240), received between Dec 10, 2018 and May 5, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• InjuryMay 5, 2026Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION.THE PATIENT UNDERWENT FIBULAR ARTERY AND TIBIOFIBULAR TRUNK ANGIOPLASTY. A 300 CM J-TIP PT? GUIDEWIRE WAS INSERTED INTO A NON-LESION SEGMENT OF THE INFRAPATELLAR ARTERY. DURING ADVANCEMENT, THE TIP OF THE GUIDEWIRE DETACHED. THE SEPARATED SEGMENT WAS SUCCESSFULLY RETRIEVED BY CATHETER ASPIRATION, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084090 ↗
• MalfunctionAug 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH MW5172268 THAT GUIDEWIRE DETACHMENT OCCURRED. A 300CM J-TIP PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING ANGIOGRAM, THE WIRE BROKE INSIDE THE PATIENT. ALL OF THE PIECES WAS RECOVERED FROM THE PATIENT AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751410 ↗
• InjuryMay 8, 2025Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED IN ANTERIOR TIBIAL ARTERY (ATA). A 300CM MODERATE SUPPORT, J-TIP (PT2 5PK) GUIDEWIRE WAS SELECTED FOR VASCULAR INTERVENTION BELOW THE KNEE (BTK). HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE TIP BENT AND WAS BROKEN AND DIFFICULT TO RECOVER FROM VESSEL. THE TIP WAS CAUGHT AND REMOVED USING A SNARE TOOL, AND THE PROCEDURE WAS COMPLETED USING NEW GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985340 ↗
• MalfunctionSep 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. A 300CM J-TIP PT2 GUIDEWIRE WAS SELECTED FOR USE DURING A VASCULAR ANGIOPLASTY. DURING PREPARATION IT WAS NOTICED THAT THE GUIDEWIRE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691706 ↗
• InjuryMay 30, 2023Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA PEDAL ACCESS THROUGH THE ANTERIOR TIBIAL ARTERY (ATA). THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED PERONEAL ARTERY (PA). A 300CM MODERATE SUPPORT PT2 GUIDEWIRE WAS ADVANCED FOR TREATMENT. THE WIRE WAS LOOPED UP OVER TIBIOPERONEAL (TP) TRUNK INTO PA. THE ATA INTO THE TP TRUNK WAS BALLOONED, HOWEVER, DURING INSERTION OF THE BALLOON, THE MID OF THE WIRE BROKE AT THE LEVEL OF THE TP TRUNK. THE BROKEN WIRE WAS COMPLETELY REMOVED USING A SNARE THROUGH THE ATA. THE PROCEDURE WAS THEN STOPPED AS REMOVAL OF THE WIRE PIECE TOOK TOO MUCH TIME AND RADIATION. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THIS IS VIA FACILITY MAUDE REFERENCE # MW5117595.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021262 ↗
• InjuryDec 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP BREAK AND CANCELLED PROCEDURE OCCURRED. A 300CM PT2 GUIDEWIRE WAS SELECTED FOR USE IN A NON TORTUOUS 85% STENOSED LESION BELOW THE KNEE. THE LESION WAS NOT PREDILATED. THE PT2 PASSED THE LESION AND A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ADVANCED OVER THE PT2 GUIDEWIRE. THE TIP OF THE PT2 GUIDEWIRE WAS OBSERVED BROKEN. THE PT2 WAS REMOVED AND THE PROCEDURE STOPPED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951621 ↗
• MalfunctionOct 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE BREAK OCCURRED. A 300CM PT2 MODERATE SUPPORT GUIDEWIRE WAS SELECTED FOR USED. HOWEVER, DURING PREPARATION, A GUIDEWIRE BREAKAGE WAS IDENTIFIED UPON RETRACTION OF THE PACKAGING, AND THE DEVICE WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION POST PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621729 ↗
• InjuryDec 10, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE AND A PIECE REMAINED INSIDE THE PATIENT. A 300CM PT2 GUIDEWIRE WAS SELECTED FOR USE FOR A PROCEDURE IN THE LOWER LEG. THE PATIENT HAD GRADE 4 CALCIFICATION ON THE LOWER LEG. THE WIRE BROKE AS THE DOCTOR PASSED THE STENOSIS. THE PIECE OF WIRE REMAINED IN THE PATIENT AND COULD NOT BE RECOVERED. ACCORDING TO THE PHYSICIAN, THE STRONG CALCIFICATION WAS TO BLAME FOR BREAKING THE WIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8146314 ↗