Orbiter™ ST M0043200020Recalls & reported problems
Boston Scientific Corporation · Bidirectional Steerable Diagnostic Catheter · 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 08714729877776), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
- Positioning Problem1
Patient problems
- 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.
MalfunctionMay 15, 2019Material Integrity Problem; Positioning Problem; Material Integrity Problem; Positioning Problem
USER FACILITY MEDWATCH # (B)(4). IT WAS REPORTED THAT CATHETER TIP DAMAGE OCCURRED. DURING A MAPPING AND ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (SVT), THE ORBITER ST CATHETER WAS DIFFICULT TO MANEUVER IN BOTH DIRECTIONS PER THE PHYSICIAN. THE PHYSICIAN PLACED IT IN THE BODY AND AFTER A PERIOD OF TIME, IT WAS DETERMINED THAT THE CATHETER WAS NOT WORKING PROPERLY AND REMOVED IMMEDIATELY. THE CATHETER WAS NOTED TO HAVE DAMAGE AT THE DIAGNOSTIC TIP, THE METAL WAS EXPOSED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8611599 ↗
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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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