PT²™ H74938931040Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729471226), received between Oct 18, 2018 and Aug 18, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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. How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306573 ↗
• InjuryFeb 27, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SEGMENT AROUND THE AXILLARY ARTERY IN THE ARM. A PT2 MODERATE SUPPORT 300 CM STR GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE PT2 GUIDEWIRE BROKE AFTER BEING INSERTED INTO THE VEIN. THE DEVICE WAS REMOVED USING A VERY SMALL RETRIEVAL TOOL TO EXTRACT IT OUT, AND THE PROCEDURE WAS COMPLETED USING ANOTHER BRAND OF GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21480583 ↗
• InjuryMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, AND DEVICE FRAGMENT REMAINED IN PATIENT. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 300CM MODERATE SUPPORT STRAIGHT PT GUIDEWIRE WAS ADVANCED INTO THE LESION. HOWEVER, DURING THE PROCEDURE WITH DIFFICULT MANIPULATION, THE TIP OF THE GUIDEWIRE FRACTURED INSIDE THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 2-3CM TIP OF THE DEVICE REMAINED INSIDE THE PATIENT BODY SINCE IT COULD NOT BE REMOVED. THE PATIENT WAS SUPPOSED TO HAVE BLOOD VESSEL OCCLUSION TREATED WITH MEDICINE AND WILL BE TRANSFERRED TO A HIGHER-LEVELLED HOSPITAL FOR FURTHER TREATMENT.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 18869285 ↗
• InjuryFeb 29, 2024Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 300CM PT2 GUIDEWIRE WAS SELECTED FOR USE. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH THE WIRE; HOWEVER, WHEN THE PHYSICIAN PULLED BACK TO REDIRECT THE WIRE, THE TIP OF THE WIRE BROKE OFF AND REMAINS IN THE PROXIMAL RCA. NO ATTEMPT WAS MADE TO RETRIEVE THE WIRE BECAUSE IT WAS IMBEDDED INTO THE PLAQUE. ANOTHER OF THE SAME DEVICE WAS USED AND A STENT WAS IMPLANTED OVER THE WIRE FRAGMENT, LEAVING THE WIRE JAILED WITHIN THE ARTERIAL WALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18813067 ↗
• InjurySep 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED ARTERY OF THE LEG. A 300CM STR PT GUIDEWIRE WAS ADVANCED FOR CROSSING THE LESION. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE OFF AND WAS LEFT IN THE ARTERY OF THE PATIENT. THE PHYSICIAN USED A SNARE AND WAS ABLE TO REMOVE THE DETACHED TIP OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447850 ↗
• InjurySep 14, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINS IN THE PATIENT. A 300CM MODERATE SUPPORT STRAIGHT PT GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP DETACHED AND WAS REMAINS IN THE PATIENT. THE TIP WAS TRAPPED IN AN OCCLUSION, SO REPORTED AS MINIMAL RISK. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12469415 ↗
• MalfunctionSep 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE WIRE DETACHED. A 300CM PT GUIDEWIRE WAS SELECTED FOR USE. DURING UNPACKING, THE TIP DETACHED WHEN IT WAS REMOVED FROM THE PACKAGING COIL. THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518218 ↗
• InjuryOct 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED INSIDE THE PATIENT. VASCULAR ACCESS WAS GAINED THROUGH A RETROGRADE PUNCTURE VIA THE DORSALIS PEDIS ARTERY. THE TARGET ANATOMY WAS LOCATED WITHIN AN ARTIFICIAL VEIN INTERPOSITION ON THE PROXIMAL LOWER LEG. THE PATIENT HAD A POPLITEAL BYPASS WITH ENTRAPMENT SYNDROME WITHIN THE TRANSITION INTERPOSITION-A. FIBULARIS ON THE RIGHT. A 300 CM PT2 GUIDEWIRE WAS SELECTED TO TREAT STENOSIS BELOW THE RIGHT KNEE. THE WIRE WAS ADVANCED TO THE STENOSIS. THE WIRE TIP DETACHED FROM THE WIRE. THE TIP REMAINED INSIDE THE PATIENT, AND THE REST OF THE WIRE WAS REMOVED. AN INTERVENTIONAL ATTEMPT WAS NOT MADE TO REMOVE THE DETACHED WIRE TIP. IT WAS NOT POSSIBLE TO PROBE THE DISTAL ANASTOMOSIS BYPASS FOR DILATION DURING THE PROCEDURE. THE PROCEDURE WAS ENDED AND THE PATIENT HAD NO CHANGE IN CONDITION. A PREVIOUSLY NECESSARY BYPASS ANASTOMOSIS REVISION ALONG WITH A SURGICAL SALVAGE WHERE THE DETACHED TIP WAS RETRIEVED WAS COMPLETED TWO DAYS LATER SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9218253 ↗
• MalfunctionOct 18, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE 300CM MODERATE SUPPORT STRAIGHT PT2 WIRE BROKE DURING DILATION OF A NON-BSC BALLOON. THE PHYSICIAN WAS ABLE TO GET THE WIRE OUT AND THERE WERE NO PATIENT ISSUES. THE DEVICE WAS RETURNED AND ANALYSIS WAS COMPLETED. ANALYSIS OF RETURNED PRODUCT REVEALED ONE KINK APPROXIMATELY AT THE DISTAL SECTION. ALSO IT WAS FOUND THE WIRE BROKEN AND SLIGHTLY BENT ON ITS DISTAL TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979730 ↗