PT²™ H74938931020Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729471141), received between Dec 10, 2018 and Dec 10, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2018Fracture; Fracture
IT WAS REPORTED THAT GUIDE WIRE FRACTURE OCCURRED. TWO 300 CM LIGHT SUPPORT STRAIGHT TIP PT WIRES WERE USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, THE FIRST WIRE BROKE AND WAS REMOVED WITH THE HELP OF A BALLOON. THE SECOND WIRE ALSO BROKE, BUT REQUIRED A SUPERFICIAL FEMORAL SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8146765 ↗InjuryDec 10, 2018Fracture; Fracture
IT WAS REPORTED THAT GUIDE WIRE FRACTURE OCCURRED. TWO 300CM LIGHT SUPPORT STRAIGHT TIP PT WIRES WERE USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, THE FIRST WIRE BROKE AND WAS REMOVED WITH THE HELP OF A BALLOON. THE SECOND WIRE ALSO BROKE, BUT REQUIRED A SUPERFICIAL FEMORAL SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8146758 ↗
Other WIRE, GUIDE, CATHETER devices
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- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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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