PT²™ H7493893101J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729471127), received between Oct 20, 2021 and Jun 5, 2025 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 185CM PT2 LIGHT SUPPORT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE LINE IMPLANTATION PROCEDURE, THE GUIDEWIRE WAS BROKEN. THE DEVICE WAS REMOVED WITHOUT CAUSING ANY HARM TO THE PATIENT. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152004 ↗
• InjuryApr 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED RESULTED IN UN-RETRIEVED DEVICE FRAGMENT IN PATIENT. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED OBTUSE MARGINAL BRANCH. A 185CM PT2 GUIDEWIRE WAS SELECTED FOR USED. UPON REMOVAL OF THE WIRE, THE DISTAL TIP, SEPARATED FROM THE MAIN WIRE, AND WAS LEFT IN THE DISTAL ARTERY. NO ATTEMPT WAS MADE TO RETRIEVE THE WIRE FROM THE PATIENT, AS IT REMAINS IN A SMALL VESSEL. A DIFFERENT WIRE WAS PLACED IN THE SAME VESSEL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19029147 ↗
• MalfunctionMar 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 185CM LIGHT SUPPORT J-TIP PT2 GUIDEWIRE WAS USED DURING THE PROCEDURE; HOWEVER, THE GUIDEWIRE TIP BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499115 ↗
• InjuryOct 20, 2021Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 185CM J-TIP PT GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, WHILE MANIPULATING THE GUIDE WIRE INSIDE THE VESSEL, RESISTANCE WAS ENCOUNTERED AND 3CM OF THE GUIDE WIRE TIP DETACHED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FRAGMENT BUT IT WAS NOT POSSIBLE TO WITHDRAW AND WAS LEFT INSIDE THE ARTERY. FLOW OF THE VESSEL WAS NOT COMPROMISED AND VESSEL DAMAGE WAS NOT NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT TO MONITOR POSSIBLE COMPLICATIONS OF BLEEDING FROM THE RIGHT GROIN. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12664497 ↗