EDWARDS DILATOR KIT 9100DKSARecalls & reported problems
Edwards Lifesciences LLC · EDWARDS DILATOR KIT · 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 00690103192391), received between Sep 2, 2022 and Sep 2, 2022 — 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
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2022Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem
AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE OF A 23MM SAPIEN 3 ULTRA VALVE, IT WAS NOTED THERE WAS ANTICIPATED VASCULAR DISEASE OF THE ACCESS VESSELS. THE VESSEL WAS DILATED WITH A 7MM SHOCKWAVE BALLOON AND THE 16FR DILATOR THAT CAME WITH THE ESHEATH+ KIT. AN ADDITIONAL ANGIOPLASTY WAS PERFORMED ON THE VESSEL WITH AN 8MM SHOCKWAVE BALLOON. AN EDWARDS DILATOR KIT WAS THEN OPENED AND THE ESHEATH+ WAS WITHDRAWN FROM THE PATIENT AND EXCHANGED FOR A 18FR DILATOR. THE DILATOR WAS WITHDRAWN, AND A NEW ESHEATH+ WAS INSERTED AND ADVANCED IN THE PATIENT. AFTER THE DILATOR WAS WITHDRAWN, IT WAS INSPECTED AND OBSERVED TO HAVE BEEN GOUGED WITH PIECES SHAVING OFF. ONE PIECE WAS NOTED TO HAVE FALLEN OFF; HOWEVER, THERE WERE NO DILATOR PIECES FOUND IN THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15348886 ↗
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- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
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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