25MM X 4CM X 130CM EDWARDS BALLOON CATHETER 9350BC25Recalls & reported problems
Edwards Lifesciences LLC · EDWARDS BALLOON CATHETER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103193459), received between Feb 26, 2021 and Jul 27, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Remove1
- Material Rupture1
Patient problems
- Great Vessel Perforation1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, AN ECHO PERFORMED MINUTES BEFORE DISCHARGE AFTER A SUCCESSFUL TF TAVR CASE REVEALED A CONTAINED ROOT RUPTURE. THE PATIENT'S CHEST WAS OPENED AND THE ROOT RUPTURE WAS REPAIRED AND THE PATIENT HAS SINCE BEEN DISCHARGED. OF NOTE, THE PATIENT HAD A TYPE 0 BICUSPID VALVE AND BAV WAS PERFORMED MULTIPLE TIMES (WITH AN EW 25MM BAV) BEFORE THE 29MM SAPIEN 3 VALVE WAS IMPLANTED. THE S3 VALVE WAS EXPLANTED AND A FULL BENTAL PROCEDURE WAS PERFORMED DURING THE INTERVENTION. THERE WERE NO REPORTED MALFUNCTIONS OF ANY EDWARDS DEVICES.
Patient problems: Great Vessel Perforation
MAUDE report 12229115 ↗InjuryFeb 26, 2021Difficult to Remove; Material Rupture
AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING THE BAV, THE BALLOON RUPTURED ON A PIECE OF CALCIUM IN THE ANNULUS. THE BALLOON WAS ATTEMPTED TO BE PULLED OUT THROUGH THE 14F ESHEATH BUT IT DID NOT COME ALL THE WAY INTO THE SHEATH. AN ATTEMPT TO PULL EVERYTHING OUT AS ONE THROUGH THE ARTERIOTOMY WAS PERFORMED BUT COULD NOT PASS THOUGH. A CUT DOWN ON THE RIGHT GROIN WAS PERFORMED TO REMOVE THE ENTIRE BALLOON OUT SAFELY. VASCULAR REPAIR WAS PERFORMED BY PLACING A STENT GRAFT TO REPAIR THE DAMAGED INTIMA OF THE RIGHT EXTERNAL ILIAC. THE REPAIR WAS SUCCESSFUL BUT THE TAVR WAS ABORTED AND WILL BE SCHEDULED FOR ANOTHER DAY.
Patient problems: Insufficient Information
MAUDE report 11386739 ↗
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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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