Stingray™ H749M3012A0Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729837541), received between Dec 17, 2018 and May 2, 2024 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Entrapment of Device1
Patient problems
- Low Blood Pressure/ Hypotension1
- No Consequences Or Impact To Patient1
- Perforation of Vessels1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 185CM STINGRAY GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE PERFORATED THE LEFT ANTERIOR DESCENDING ARTERY CAUSING THE PATIENT TO EXPERIENCE HYPOTENSION. A BALLOON WAS USED TO TREAT THE PERFORATION AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE POST PROCEDURE AND EXPECTED TO FULLY RECOVER. HOWEVER, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND CORONAY ARTERY BYPASS GRAFT (CABG) SURGERY WAS PLANNED.
Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels
MAUDE report 19235125 ↗MalfunctionDec 17, 2018Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT THE WIRE FROZE INSIDE THE STINGRAY BALLOON. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A 185CM STINGRAY GUIDEWIRE AND A STINGRAY LP CATHETER WERE SELECTED FOR USE. DURING THE PROCEDURE, THE STINGRAY BALLOON WAS DISTALLY DOWN WITH THE WIRE TO DO RE-ENTRY; HOWEVER, THE WIRE FROZE INSIDE THE STINGRAY BALLOON. THE DEVICES WERE THEN TAKEN OUT FROM THE VESSEL AND THE VESSEL WAS SUCCESSFULLY OPENED WITH THE USE OF STENTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICES WERE REMOVED SAFELY FORM THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFUL WITH DIFFERENT TECHNOLOGY. NO PHYSICAL DAMAGE WERE OBSERVED ON THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8169222 ↗
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- 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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