PT GraphixRecalls & reported problems across all models
Boston Scientific Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 6 models of PT Graphix by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2016 and Sep 16, 2025 — classified as 18 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PT Graphix problems
Device problems
- Detachment of Device or Device Component15
- Fracture4
- Break3
- Difficult to Remove3
- Difficult to Advance2
- Adverse Event Without Identified Device or Use Problem1
- Entrapment of Device1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient11
- Device Embedded In Tissue or Plaque8
- No Clinical Signs, Symptoms or Conditions2
- Chest Pain1
- Failure of Implant1
- Insufficient Information1
- Obstruction/Occlusion1
- Perforation of Vessels1
PT Graphix models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PT Graphix™ H74914902011WIRE, GUIDE, CATHETER9 reports
- PT Graphix™ H7491490201J1WIRE, GUIDE, CATHETER5 reports
- PT Graphix™ H7491490301J1WIRE, GUIDE, CATHETER4 reports
- PT Graphix™ H74914914011WIRE, GUIDE, CATHETER3 reports
- PT Graphix™ H74914903011WIRE, GUIDE, CATHETER1 report
- PT Graphix™ H7491491401J1WIRE, GUIDE, CATHETER1 report
Recent PT Graphix adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2025Break; Physical Resistance/Sticking
AT THE APPROXIMAL MID THIGH, A LARGE AREA OF TOTAL OCCLUSION WAS NOTED. THE WIRE GOT STUCK. A SMALL PORTION OF THE TIP OF THE WIRE SNAPPED OFF. THE MD SHOT FURTHER PICTURES WHICH CONFIRMED CHRONIC TOTAL OCCLUSION. THE WIRE REMAINED IN THE PATIENT'S RIGHT THIGH.
Patient problems: Foreign Body In Patient; Obstruction/Occlusion
MAUDE report 23061900 ↗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 ↗MalfunctionMar 14, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 182CM J PT GRAPHIX GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, WHILE CROSSING THE LESION, A PIECE OF THE GUIDEWIRE BROKE OFF IN THE VESSEL. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606924 ↗InjuryFeb 16, 2024Fracture; Fracture
IT WAS REPORTED THAT THE COATING PEELED REQUIRING INTERVENTION. THE 40% STENOSED TARGET LESION WAS LOCATED IN THE SLIGHTLY TORTUOUS LEFT POPLITEAL ARTERY/TIBIA PERONEAL TRUNK ARTERY. A 300CM PTGRAPHIX GUIDEWIRE WAS ADVANCE TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE HYDROPHILIC COATING CAME OFF INSIDE THE PATIENT. THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED, AND ANGIOPLASTY WAS PERFORMED TO PUSH THE HYDROPHILIC COATING OUT OF THE WAY. THE DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT HARM WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18725070 ↗InjuryApr 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5115812 THAT DISTAL TIP DETACHMENT OCCURRED. A 182CM CHOICE PT GRAPHIX GUIDEWIRE WAS USED DURING A LEFT HEART CATHETERIZATION. HOWEVER, WHILE THE WIRE WAS BEING REMOVED, THE TIP OF THE WIRE SHEARED OFF. THE DEVICE FRAGMENT WAS RETAINED INSIDE THE VESSEL. SUBSEQUENTLY, CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) WAS PERFORMED FOR THREE TIMES. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 16724184 ↗InjuryFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND UNRETRIEVED DEVICE FRAGMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY STENOSIS. A 182CM PT GRAPHIX GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE GUIDEWIRE FRACTURED APPROXIMATELY BETWEEN BODY AND TIP. THE GUIDEWIRE TIP DEPRECATED FROM WIRE BODY. THE DETACHED PORTION WAS REMOVED; BUT A PORTION REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS THE PATIENT WAS SENT FOR TRANSTHORACIC SURGERY DUE TO COMPLICATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT WIRE TIP DISLODGED FROM WIRE BODY AND COULD NOT BE RETRIEVED PERCUTANEOUSLY. MOREOVER, THE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS DISCONTINUED IN LEU OF THE SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 16295077 ↗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 ↗InjuryOct 12, 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 65% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ANTERIOR DESCENDING ARTERY. A 182CM GRAPHIX GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, WHILE MANIPULATING THE GUIDEWIRE INSIDE THE VESSEL, RESISTANCE WAS ENCOUNTERED AND APPROXIMATELY 3CM OF THE GUIDEWIRE TIP WAS LEFT INSIDE THE ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DISLODGED GUIDEWIRE TIP BUT IT WAS NOT POSSIBLE TO WITHDRAW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT DETACHED TIP REMOVAL USING A SNARE WAS ATTEMPTED WITHOUT SUCCESS.
Patient problems: Foreign Body In Patient
MAUDE report 12620143 ↗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 ↗InjuryJun 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A GUIDEWIRE TIP FRACTURE OCCURRED. AN ANGIOPLASTY WAS PERFORMED FOR CRITICAL LIMB ISCHEMIA. A 300CM PT GRAPHIX GUIDEWIRE WAS USED TO CROSS THE LESION, BUT A FRAGMENT OF THE WIRE TIP BROKE OFF AND LODGED IN PERIVASCULAR TISSUE, FOLLOWING PERFORATION OF A VESSEL. A DECISION WAS MADE TO LEAVE THE FRAGMENT IN SITU AS IT WOULD BE LESS RISKY THAN ATTEMPTING RETRIEVAL. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE WELL THROUGHOUT THE PROCEDURE AND HAD NO CLINICAL IMPACT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Foreign Body In Patient; Perforation of Vessels
MAUDE report 11987167 ↗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 ↗MalfunctionJun 12, 2020Positioning Problem
THE PATIENT WAS UNDERGOING A PLACEMENT OF THREE CORONARY STENT IN HIS RIGHT CORONARY ARTERY. WHILE REMOVING HIS CORONARY WIRE AFTER STENT PLACEMENT, IT WAS NOTED THE EMBOLIZATION OF THE NITINOL WIRE TIP COVERING IN THE RIGHT CORONARY ARTERY, ADJACENT TO THE STENT. FLUOROSCOPY CONFIRMED THE NITINOL COVERING OF THE TIP OF THE WIRE WAS IN THE RCA. A DECISION WAS MADE TO REWIRE WITH A DIFFERENT WIRE, STENTING THE AREA AND SECURING THE TIP TO THE VESSEL WALL.
Patient problems: Failure of Implant
MAUDE report 10147908 ↗InjuryJun 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 182CM J CHOICE PT GRAPHIX STANDARD GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE TIP OF THE GUIDEWIRE WAS FRACTURED. THE DETACHED TIP COULD NOT BE RETRIEVED WITH A SNARE. AN UNKNOWN DRUG-ELUTING STENT WAS USED TO AFFIX AND APPOSE THE DETACHED TIP IN PLACE IN THE RCA. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10133993 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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