Dreamwire M00556120Recalls & reported problems
Boston Scientific Corporation · High Performance Guidewire · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729779568), received between Nov 22, 2019 and Nov 22, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PORTION OF THE GUIDEWIRE SHEATH BROKE OFF AND WAS RETAINED IN THE BILIARY TRACT. ON (B)(6) 2019, THE DETACHED PORTION WAS RETRIEVED (UNKNOWN WHAT DEVICE WAS USED TO RETRIEVE).
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 9363549 ↗
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- Amplatz Super Stiff M0066401090Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY21 reports
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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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