ACUITY Whisper View™ 4648Recalls & reported problems
Boston Scientific Corporation · Guide Wire with Hydrophilic Coating · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00802526512988), received between Dec 27, 2017 and Sep 25, 2026 — classified as 5 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (7 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
- Material Integrity Problem7
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
Patient problems
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient2
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Foreign Body In Patient
MAUDE report 50896737 ↗MalfunctionDec 19, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE TIP OF THIS GUIDEWIRE HAD BROKEN OFF INTO ONE OF THE BRANCHES OF THE CORONARY VEIN. THE GUIDEWIRE TIP WAS NOT RETRIEVED FROM THE PATIENT'S BODY. NO ADVERSE PATIENT EFFECTS WERE REPORTED BUT THE PATIENT IS NO LONGER MRI COMPATIBLE.
Patient problems: Foreign Body In Patient
MAUDE report 16002964 ↗InjuryFeb 1, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE TIP OF THE WHISPER WIRE SEPARATED FROM THE MAIN PART OF THE WIRE AND WAS LEFT IN THE BODY OF THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 9656667 ↗InjuryAug 5, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT AS THE LEAD AND WIRE WAS PULLED BACK THROUGH THE VEIN, THE TIP OF THE WIRE BROKE OFF AND REMAINED IN THE DISTAL BRANCH OF THE VESSEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8862519 ↗MalfunctionJul 23, 2019Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem
IT WAS REPORTED THAT MULTIPLE GUIDEWIRES HAD BEEN USED DURING A DIFFICULT IMPLANT PROCEDURE. WHEN THE PHYSICIAN USED THE FINAL WIRE, IT WAS OBSERVED THAT APPROXIMATELY 3 CENTIMETERS OF A DIFFERENT GUIDEWIRE HAD BROKEN OFF AND WAS ABANDONED WITHIN THE SINUS CORONARY BRANCH. THE PATIENT WAS STABLE WITH NO ADDITIONAL CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8818687 ↗InjuryMay 7, 2019Material Integrity Problem; Material Integrity Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DISTAL END OF WHISPER WIRE WAS RETAINED IN CORONARY SINUS. ADDITIONALLY, THE PATIENT REMAINED STABLE AND RECEIVED NEW IMPLANT. THE PRODUCT WAS USED AT IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8589287 ↗InjuryMay 6, 2019Material Integrity Problem; Material Integrity Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS WHISPER WIRE BROKE OFF AND RETAINED IN CORONARY SINUS. THE PRODUCT WAS USED AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8581330 ↗InjuryDec 27, 2017Material Integrity Problem; Material Integrity Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING USE OF THIS GUIDEWIRE FOR IMPLANT OF ANOTHER MANUFACTURER'S LEAD, THE TIP OF THE GUIDEWIRE BROKE OFF AND REMAINS IN THE PATIENT. THE PHYSICIAN DID NOT PLAN TO PERFORM ANY ADDITIONAL INTERVENTION TO REMOVE THE PORTION OF THE GUIDEWIRE AND PLANNED TO LEAVE IT AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7148842 ↗
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.
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