PT²™ H74938931010Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729471103), received between Dec 13, 2018 and Jul 29, 2026 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Detachment of Device or Device Component

  It was reported that a device issue occurred resulting in patient complications.On an unknown date in 2021, the patient underwent a percutaneous coronary intervention (PCI) at an unknown facility. During the procedure, a185cm Straight PT2 guidewire was cut in the left circumflex artery (LCX). Retrieval was unsuccessful, and the fragment remained inside the body. In (b)(6) 2026, the patient presented with chest pain and was hospitalized. Coronary angiogram (CAG) was performed to investigate the chest pain. A 75% stenosed lesion was located in the non-tortuous LCX. During the CAG, the previously retained guidewire fragment was no longer visible on fluoroscopy. A non-contrast CT scan was also performed and demonstrated that the high-attenuation structure previously observed in that same area had disappeared. As per radiologist interpretation, a high-attenuation structure of similar size was identified within the splenic artery. No additional details were provided.

  Patient problems: Back pain; Chest Pain; Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 50074274 ↗
• MalfunctionJul 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS A 100% CHRONIC TOTAL OCCLUSION LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 185CM STRAIGHT PT? GUIDEWIRE WAS ADVANCED INTO THE LESION. DURING THE PROCEDURE, THE RADIOPAQUE TIP OF THE GUIDEWIRE WAS OBSERVED TO HAVE DETACHED. THE DETACHED COMPONENT DID NOT MIGRATE AND REMAINED LODGED IN THE DISTAL RCA. NO RETRIEVAL ATTEMPTS WERE MADE DUE TO THE LENGTH OF THE PROCEDURE AND CUMULATIVE RADIATION EXPOSURE. THE PHYSICIAN DETERMINED THAT RETRIEVAL WAS NOT WARRANTED. THE PATIENT REMAINED STABLE THROUGHOUT AND AFTER THE PROCEDURE AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 25803803 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A PT2 GUIDEWIRE WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) AT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. UPON OPENING THE PACKAGE, A BREAK IN THE GUIDEWIRE SHAFT WAS OBSERVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS OCCURRED, AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489598 ↗
• MalfunctionApr 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A PT2 LIGHT SUPPORT 18 5CM STRAIGHT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE GUIDEWIRE WAS FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785335 ↗
• MalfunctionJul 24, 2024Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-JUL-2024. IT WAS REPORTED THAT GUIDEWIRE KINKED WAS ENCOUNTERED. DURING UNPACKING, A 185CM STRAIGHT PT2 LIGHT SUPPORT GUIDEWIRE WAS FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, THE RETURNED DEVICE ANALYSIS REVEALED THAT THE DISTAL END HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822894 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. DURING THE UNPACKING OF 185CM PT2 GUIDEWIRE, IT WAS OBSERVED THAT THE WIRE SPLIT UP BUT DID NOT BREAK OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615985 ↗
• InjuryNov 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY OR POSTEROLATERAL BRANCH. A 185CM STRAIGHT PT2 GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS SEPARATED SLIGHTLY LONGER THAN THE MIDDLE OF THE RADIOPAQUE MARKER. THE SEPARATED PART WAS INSIDE THE PATIENT BODY AND THE REMAINING WIRE WAS MISSING. THE PROCEDURE WAS CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12787162 ↗
• MalfunctionJul 21, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRODUCT PACKAGE WAS COMPROMISED. A PT2 LIGHT SUPPORT 185CM STRAIGHT, 1-PACK GUIDEWIRE WAS UNPACKED. HOWEVER, IT WAS NOTED THAT THE SEAL WAS BROKEN. THE DEVICE NEVER ENTERED INTO THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204359 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT A COATING PROBLEM OCCURRED. A 185CM STRAIGHT, PT2 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE GUIDEWIRE WAS KINKED AND THERE WAS A PROBLEM WITH THE COATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773974 ↗
• MalfunctionFeb 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. DURING UNPACKING OF A 185CM PT GUIDEWIRE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386261 ↗
• MalfunctionDec 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A PT2 LIGHT SUPPORT 185CM STRAIGHT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE DEVICE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10949313 ↗
• MalfunctionJun 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 185 CM PT2 GUIDE WIRE WAS SELECTED FOR USE; HOWEVER, AFTER UNPACKING, IT WAS FOUND THAT THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10158124 ↗
• MalfunctionApr 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LOWER LIMB. A 185CM PT2 GUIDEWIRE WAS USED, HOWEVER; THE WIRE FRACTURED WHILE INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986027 ↗
• InjuryAug 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 185CM PT2 GUIDE WIRE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT UPON PULLING BACK THE GUIDE WIRE, THE TIP CAUGHT ON THE STENT STRUTS AND DETACHED. THE PHYSICIAN WAS UNABLE TO SNARE THE RADIOPAQUE WIRE TIP AND EVENTUALLY STENTED A 2.5X16 SYNERGY STENT AGAINST THE BROKEN TIP IN THE PROXIMAL LAD. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8884228 ↗
• MalfunctionJun 25, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE WAS OBSERVED DURING PREPARATION. THREE 185CM PT GUIDEWIRES WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE FIRST GUIDEWIRE WAS REMOVED FROM THE PACKAGING AND THE WIRE WAS NOTED TO BE DAMAGED. THE TIP OF THE WIRE HAD NO COATING. THE SECOND AND THIRD GUIDEWIRES WERE REMOVED FROM THE PACKAGING AND THE TIP BROKE DURING TIP FORMING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8731634 ↗
• MalfunctionJun 25, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT A TIP BREAK OCCURRED DURING PREPARATION. THREE 185CM PT GUIDEWIRES WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE FIRST GUIDEWIRE WAS REMOVED FROM THE PACKAGING AND THE WIRE WAS NOTED TO BE DAMAGED. THE TIP OF THE WIRE HAD NO COATING. THE SECOND AND THIRD GUIDEWIRES WERE REMOVED FROM THE PACKAGING AND THE TIP BROKE DURING TIP FORMING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8731632 ↗
• MalfunctionJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP BREAK OCCURRED DURING PREPARATION. THREE 185CM PT GUIDEWIRES WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE FIRST GUIDEWIRE WAS REMOVED FROM THE PACKAGING AND THE WIRE WAS NOTED TO BE DAMAGED. THE TIP OF THE WIRE HAD NO COATING. THE SECOND AND THIRD GUIDEWIRES WERE REMOVED FROM THE PACKAGING AND THE TIP BROKE DURING TIP FORMING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE COATING ON THE FIRST GUIDEWIRE WAS FLAKING. THE THIRD GUIDEWIRE HAD FLAKING COATING NOT A TIP BREAK AS ORIGINALLY REPORTED. THESE ISSUES OCCURRED OUTSIDE THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8731630 ↗
• InjuryJan 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE'S TIP DETACHED AND THE DEVICE'S TIP WAS LEFT INSIDE THE PATIENT. A 185CM LIGHT SUPPORT STRAIGHT TIP PT2 GUIDEWIRE WAS SELECTED FOR USE, IT WAS NOTED THAT THE TIP IF THE GUIDEWIRE SEPARATED AND IS LOCATED IN THE SEPTAL BRANCH. REMOVAL OF THE FRACTURED TIP WAS NOT ATTEMPTED AS THIS WOULD PURPOSE RISK TO THE PATIENT, THE PHYSICIAN DETERMINED THAT THE FRACTURED TIP TO BE UNREACHABLE. THE PATIENT WAS BROUGHT BACK THE FOLLOWING DAY AND WAS DOING FINE. THE PATIENT'S OM2 VESSEL REMAINS PATENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8227618 ↗
• InjuryDec 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 185CMLIGHT SUPPORT STRAIGHT TIP PT2 GUIDEWIRE WAS INSERTED INTO THE TARGET LESION THAT WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. HOWEVER, DURING THE PROCEDURE THE TIP OF THE WIRE BROKE OFF. THE TIP WAS SNARED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162345 ↗