Peripheral RotaWire™ and wireClip® Torquer M0011373310Recalls & reported problems
Boston Scientific Corporation · Guidewire and Guidewire Manipulation Device · Class 2
All models of Peripheral RotaWire and wireClip Torquer (2)
Data updated Oct 18, 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 08714729863632), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP BROKE OFF AND WAS LEFT INSIDE THE PATIENT. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A PERIPHERAL ROTAWIRE GUIDEWIRE AND A PERIPHERAL ROTALINK PLUS WERE SELECTED FOR USE. DURING THE PROCEDURE, THE SPEED WAS SET TO 160 RPM; HOWEVER, THE SPEED REACHED UP TO 163 RPM. UPON EXCHANGING ROTAWIRE TO ANOTHER GUIDEWIRE, IT WAS NOTED THAT THE 5MM TIP OF THE ROTAWIRE BROKE OFF AND REMAINED DISTAL LAD VERY CLOSE TO THE APEX. THE PHYSICIAN BELIEVE THAT THE TIP OF THE WIRE WAS PULLED TOO HARD WHILE BEING TAKEN OUT OF THE WIRE HOOP. THE PROCEDURE PROCEEDED AS PLANNED AND COMPLETED USING ORIGINAL METHOD. THE FRAGMENT WAS NOT REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 22778236 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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