Viking™ Soft Tip M0044005040Recalls & 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
- 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 08714729879039), received between Jul 16, 2018 and Jul 16, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Tamponade1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TAMPONADE OCCURRED. A VIKING SOFT TIP DIAGNOSTIC CATHETER WAS SELECTED FOR USE DURING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA PROCEDURE WITH CRYOABLATION. PRESSURES ¿LOOKED GOOD¿ DURING THE 30-MINUTE POST ABLATION WAITING PHASE WHILE THE PATIENT WAS IN THE ROOM; HOWEVER, THE PATIENT WENT HYPOTENSIVE AND TAMPONADE OCCURRED ABOUT 15 MINUTES AFTER THE PATIENT WAS BROUGHT TO RECOVERY. TAMPONADE WAS DIAGNOSED VIA ULTRASOUND; THE LOCATION OF TAMPONADE WAS UNKNOWN. FLUID WAS REMOVED FROM THE PERICARDIAL SPACE AND THE PATIENT WAS STABLE.
Patient problems: Cardiac Tamponade
MAUDE report 7690216 ↗
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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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