Platinum Plus™ M001466040Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
All models of Platinum Plus (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729114567), received between Feb 4, 2019 and Sep 9, 2022 — classified as 1 injury, 4 malfunctions.
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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Material Integrity Problem2
- Difficult to Remove1
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient3
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 3 018/180 PLATINUM PLUS GUIDEWIRE WAS CROSSED THE LESION. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE TIP WAS PARTIALLY DISLODGED FROM THE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15396648 ↗MalfunctionJun 17, 2019Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT BALLOON BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE INNOMINATE VEIN. A 3 018/180 PLATINUM PLUS GUIDEWIRE AN A 2CM PERIPHERAL CUTTING BALLOON (PCB) WERE USED IN A PROCEDURE. WHEN THE PHYSICIAN PULLED THE PBC OUT OF THE SHEATH, THE TIP OF THE SHEATH BECAME DAMAGED AND THE BALLOON WAS STUCK. THE PHYSICIAN PULLED EVERYTHING OUT AND MANAGED TO KEEP THE WIRE ACCESS, BUT THE PHYSICIAN HAD TO CUT THE WIRE BECAUSE IT BECAME STUCK WITH THE BALLOON. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8703897 ↗MalfunctionApr 19, 2019Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IT WAS REPORTED THAT AN ENTRAPMENT OF DEVICE OCCURRED. THE ALMOST OCCLUDED AND STENOSED TARGET LESION WAS LOCATED IN AN ARTERY IN THE RIGHT LEG. A 018/180 PLATINUM PLUS-3 GUIDEWIRE WAS ADVANCE FOR USE. THE PHYSICIAN TRIED TO RECANALIZE THE CALCIFIED LESION WITH BACK AND FORTH MOVEMENT, HOWEVER THE TIP OF THE WIRE GOT STUCK IN THE LESION. THE PHYSICIAN TRIED TO PULL THE GUIDEWIRE BACK, BUT IT STUCK VERY TIGHTLY WITHIN THE LESION. DURING THE REMOVAL ATTEMPT THE GUIDEWIRE MOVED BACK AND THE WIRE STARTED TO FRAY AS THE TIP REMAINED STUCK IN THE LESION. THE DEVICE WAS COMPLETELY TAKEN OUT FROM THE PATIENT. THE PROCEDURE IS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8531480 ↗MalfunctionApr 8, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A COATING ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERY IN THE GROIN. A 018/180 PLATINUM PLUS GUIDEWIRE WAS ADVANCED. HOWEVER, WHEN THEY PUT THE WIRE THROUGH AN INTRODUCER, THE COATING OF THE WIRE STARTED SHREDDING OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8492284 ↗InjuryFeb 4, 2019Detachment 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 AN ARTERY OF THE FOOT. A 018/180 PLATINUM PLUS GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, AFTER DILATION OF THE VESSEL, THE TIP OF THE GUIDEWIRE BROKE BETWEEN 5 AND 7CM AND REMAINED IN THE VESSEL. THE ARTERY IS NOT VERY PERMEABLE PER DOPPLER. AN ATTEMPT TO RECOVER THE BROKEN TIP BY LASSO WAS PERFORMED, BUT IT TURNED OUT TO BE IMPOSSIBLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8302713 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page