PT Graphix™ H74914902011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729254928), received between Jun 28, 2016 and Aug 20, 2025 — classified as 7 injuries, 2 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. How this data works · Data updated Oct 13, 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.

• InjuryAug 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE CHOICE PT GRAPHIX INTERMEDIATE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, A PIECE OF THE WIRE BECAME DETACHED, AND THE PATIENT WAS SENT FOR BYPASS TO REMOVE THE WIRE FRAGMENT.

  Patient problems: Insufficient Information

  MAUDE report 22849787 ↗
• InjuryMar 13, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE TARGET LESION WAS STENTED LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED MID TO PROXIMAL OSTIAL RIGHT CORONARY ARTERY (RCA). A 182 PT GRAPHIX GUIDEWIRE WAS CROSSED THE LESION. HOWEVER, DURING THE REMOVAL, THE DISTAL TIP OF THE WIRE WAS CAUGHT ON CALCIUM IN OSTIAL RIGHT AND THE TIP WAS FRACTURED AT APPROXIMATELY 1.5 CM. A SNARE WAS PREPARED BUT THE TIP OF THE WIRE WAS PUSHED DOWN STREAM INTO THE RENAL ARTERY PRIOR TO BEING SNARED. FURTHERMORE, IT WAS NOTED THAT DETERMINING THE NEXT STEPS WILL BE BASED ON FEEDBACK REGARDING MAGNETIC RESONANCE IMAGING (MRI) CAPABILITIES IN FUTURE AND WHETHER THEY SHOULD STAY ON AN ANTICOAGULANT FOR LIFE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13752120 ↗
• InjuryFeb 14, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH MW5106153 THAT A GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY. A 182 GRAPHIX GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE BROKE. A PORTION OF THE DETACHED GUIDEWIRE WAS LEFT IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13525015 ↗
• MalfunctionSep 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A PT GRAPHIX GUIDEWIRE WAS SELECTED; HOWEVER DURING THE PROCEDURE THE CORONARY WIRE FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12549008 ↗
• InjurySep 21, 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. THE TARGET LESION WAS LOCATED IN THE CALCIFIED OBTUSE MARGINAL (OM). A CHOICE GRAPHIX PT INTERMEDIATE GUIDEWIRE WAS USED; HOWEVER, DURING REMOVAL, A PIECE OF THE TIP BROKE OFF IN THE OM. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO SNARE THE FRACTURED PORTION BUT WAS UNABLE TO REACH IT. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED PORTION IN THE OM AS HERE WAS NO FEAR OF PATIENT HARM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12511037 ↗
• InjuryApr 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED AND REMAINED INSIDE THE PATIENT. A PT GRAPHIX GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT CORONARY HEART DISEASE. DURING THE PROCEDURE, THE RADIOPAQUE TIP BROKE OFF. THE DEVICE FRAGMENT COULD NOT BE RETRIEVED AND WAS LEFT INSIDE THE PATIENT. THE PCI WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 11654207 ↗
• InjuryFeb 25, 2020Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE TIP DETACHED AND REMAINED IN THE PATIENT. THE 95% STENOSED LESION WAS LOCATED IN THE MEDIAL LEFT ANTERIOR DESCENDING ARTERY (LAD). SIX MONTHS PRIOR, BALLOONING AND STENTING WAS PERFORMED IN THE LAD AND THE STENT COVERED THE BIFURCATION TO A SIDE BRANCH. THE BIFURCATION LOST MORE THAN 75% LUMEN DUE TO A PLAQUE SHIFT. A PT GRAPHIX GUIDEWIRE WAS INTRODUCED TO WHERE THE STENT WAS PLACED. THE GUIDEWIRE STOPPED AT THE STENT AND COULD NO LONGER ADVANCE. THE SHAFT OF THE GUIDEWIRE WAS PULLED, BUT THE TIP DETACHED AND REMAINED IN THE SIDE BRANCH. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS STABLE. THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9750750 ↗
• InjuryDec 29, 2016Break; Material Fragmentation; Difficult to Remove; Sticking

  PT HOSPITALIZED WITH AN ACUTE CHEST PAIN SYNDROME AND RULED IN FOR A NON-STEMI. PHYSICIAN ATTEMPTED TO REPOSITION THE PT GRAPHIX GUIDEWIRE INTO THE POSTERIOR DESCENDING CORONARY ARTERY WHICH HAD A SEVERE OSTIAL STENOSIS. WHEN THE WIRE WAS BEING WITHDRAWN INTO THE DISTAL RIGHT CORONARY ARTERY, THE GUIDEWIRE BECAME ENTRAPPED AT THE DISTAL RIGHT CORONARY ARTERY, THE GUIDEWIRE BECAME ENTRAPPED AT THE DISTAL STENT EDGE AND COULD NO LONGER BE MANIPULATED. PHYSICIAN ATTEMPTED TO DISLODGE THE GUIDEWIRE AND ADVANCE IT BACK INTO THE DISTAL VESSEL, BUT IT WOULD NOT MOVE. THE WIRE WAS STUCK AT THE DISTAL EDGE. THE WIRE WAS REMOVED WITH MULTIPLE MANIPULATION AND 2 DISTAL FRAGMENTS WERE PRESENT IN THE DISTAL RIGHT CORONARY ARTERY WITH NO FLOW LIMITATION AND NO EVIDENCE OF THROMBOSIS. THE GUIDEWIRE FRAGMENT WAS ENTRAPPED AT THE DISTAL STENT EDGE IN THE DISTAL RIGHT CORONARY ARTERY. AFTER BALLOON ANGIOPLASTY AT THIS SITE, PART OF THE WIRE FRAGMENT EMBOLIZED TO THE DISTAL POSTEROLATERAL BRANCH. PART OF THE WIRE FRAGMENT REMAINED ATTACHED TO THE DISTAL STENT EDGE. THIS WAS TREATED WITH ANOTHER DRUG-ELUTING STENT IN THE DISTAL RIGHT CORONARY ARTERY TO TRAP THE GUIDEWIRE FRAGMENT AGAINST THE VESSEL WA

  Patient problems: Chest Pain; Foreign Body In Patient; Stenosis

  MAUDE report 6217865 ↗
• MalfunctionJun 28, 2016Break; Entrapment of Device

  PT WAS HAVING STENT PLACED. UNFORTUNATELY, WHILE REMOVING THE WIRE THE PROLAPSED PORTION OF THE WIRE APPARENTLY WENT UNDER THE STENT STRUT, CAUGHT THE WIRE, ACCORDIONED THE STENT SLIGHTLY AND TRAPPED THE WIRE. CONSIDERABLE EFFORTS WERE UNDERTAKEN TO ATTEMPT TO REMOVE THE WIRE. ULTIMATELY THE TIP OF THE WIRE FINALLY BROKE AND REMAINS IN THE STRUTS OF THE 2.5 X 23 XIENCE STENT, DISTALLY. THE PT WILL F/U CLINICALLY FOR FURTHER DECISIONS/ OPTIONS FOR THIS IN THE FUTURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5764660 ↗