ACUITY Whisper View™ 4647Recalls & 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
- 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 00802526512933), received between Sep 26, 2019 and Jun 10, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove2
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2022Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IT WAS REPORTED THAT THE CATHETER WOULD NOT WITHDRAW WHEN ATTEMPTING TO REMOVE AFTER THE LEFT VENTRICULAR (LV) LEAD PLACEMENT. THE PHYSICIAN THEN PULLED HARDER AND THE DISTAL TIP SHRED OFF REMAINING DISTAL TO LV LEAD. MOREOVER, THE TOP OF THE WIRE REMAINS STATIONARY IN CORONARY SINUS AS CONFIRMED THROUGH FLUOROSCOPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14655571 ↗InjurySep 26, 2019Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IT WAS REPORTED THAT DURING THE LEAD IMPLANT PROCEDURE THE TIP OF THE GUIDEWIRE BROKE OFF WHEN RETRACTED. PHYSICIAN WAS NOT ABLE TO REMOVE THE FOREIGN BODY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9125585 ↗
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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