N/A (REF BD710DF282RTS)Recalls & reported problems
Innovative Health LLC · Webster CS Bi-Directional Diagnostic EP Catheter, 7F · Class 2
- 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 10841898123269), received between Jun 21, 2024 and Jun 21, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPROCESSED WEBSTER CS DEVICE WAS REPORTED TO HAVE BEEN USED DURING A PROCEDURE THAT RESULTED IN A CORONARY SINUS PERFORATION. SEVERAL DEVICES FROM OTHER MEDICAL MANUFACTURERS WERE ALSO IN USE AT THE TIME OF THE EVENT.
Patient problems: Cardiac Perforation
MAUDE report 19586736 ↗
Other Catheter, Recording, Electrode, Reprocessed devices
- MEDLINE 401904RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls1 report
- MEDLINE 401582RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls0 reports
- MEDLINE 401474RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls1 report
- MEDLINE 81102RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710FJ282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710DF282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401448RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401222RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.