PT Graphix™ H74914914011Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · Class 2
All models of PT Graphix (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729255017), received between Jun 18, 2019 and Sep 16, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Obstruction/Occlusion1
- Perforation of Vessels1
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗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 ↗InjuryJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA USER/FACILITY MEDWATCH# (B)(4) THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT PEDAL ARTERY. A 300CM CHOICE PT GRAPHIX INTERMEDIATE GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, UPON ATTEMPTING TO REMOVE THE GUIDE WIRE AFTER BALLOON INFLATION, THE TIP BROKE OFF APPROXIMATELY 0.5CM. THE DETACHED TIP WAS UNABLE TO RETRIEVE. THE PROCEDURE ENDED LEAVING THE TIP IN PLACE AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8708020 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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