Stingray™ H749M3004A0Recalls & reported problems
Boston Scientific Corporation · Guidewire with Hydrophilic Coating · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729837527), received between Jul 5, 2019 and Jul 5, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (1 report).
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
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2019Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT A STINGRAY GUIDEWIRE BECAME STUCK IN THE STINGRAY LP. THE TARGET LESION WAS LOCATED IN THE TOTALLY OCCLUDED RIGHT CORONARY ARTERY. A STINGRAY GUIDEWIRE AND STINGRAY LP CATHETER WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WOULD NO LONGER EXIT THE CATHETER AND BECAME CAUGHT AND LODGED IN THE EXIT PORT AFTER MULTIPLE ATTEMPTS TO EXIT THE BALLOON AND ENTER THE TRUE LINE AFTER A PLANNED DISSECTION. BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT'S BODY THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8764509 ↗
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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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