Viking™ M0044000160Recalls & reported problems
Boston Scientific Corporation · Fixed Curve Diagnostic Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729878162), received between Aug 6, 2019 and Aug 8, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Mechanics Altered2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2019Mechanics Altered; Mechanics Altered
REPORTABLE BASED ON ANALYSIS COMPLETED ON 12 JUL 2019. IT WAS REPORTED THAT A VIKING CATHETER HAD ITS CURVATURE REVERSED. THE PROCEDURE WAS COMPLETED VIA A ALTERNATE METHOD WITH NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED EXPOSED SILVER EPOXY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8875522 ↗MalfunctionAug 6, 2019Mechanics Altered; Mechanics Altered
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JUL2019. IT WAS REPORTED THAT THE CATHETER CURVE WAS BAD. DURING AN ABLATION PROCEDURE WITH A VIKING ELECTRODE CATHETER, THE CATHETER CURVATURE WAS REVERSED MAKING THE DEVICE UNUSABLE. NO PATIENT COMPLICATIONS OCCURRED. DEVICE ANALYSIS REVEALED THAT ELECTRODE 5 HAD BEEN MOVED IN THE DISTAL DIRECTION EXPOSING THE SILVER EPOXY AND ELECTRODE 5 SIGNAL WIRE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8866387 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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