Xtractor 1Recalls & reported problems
Xcardia Innovation Ltd · Class 2
Data updated Oct 16, 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 37290019371008), received between Aug 2, 2023 and Aug 2, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Great Vessel Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A LEAD EXTRACTION PROCEDURE, TWO LEADS WERE ATTEMPTED TO BE REMOVED FROM A 54-YEAR OLD FEMALE PATIENT INDICATED FOR LEAD EXTRACTION PROCEDURE DUE TO ICD MALFUNCTION. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA. FLUROSCOPY AND TRANS-ESOPHAGEAL-ECHO WERE USED THROUGHOUT THE EXTRACTION PROCESS. LEADS WERE PREPARED WITH LOCKING STYLETS. THE FIRST LEAD WAS REMOVED SUCCESSFULLY WITHOUT COMPLICATION USING THE XTRACTOR DEVICE AND A LOCKING STYLET. DURING THE EXTRACTION OF THE SECOND LEAD, APPROXIMATELY AFTER PASSING THE SVC TOWARDS THE ATRIUM, A BLOOD PRESSURE DROP WAS NOTED, SUGGESTING THAT THERE WAS A TEAR IN THE SVC OR ATRIUM, WHICH WAS CONFIRMED BY ECHO. ACCORDINGLY, SURGICAL INTERVENTION BY STERNOTOMY WAS REQUIRED.
Patient problems: Great Vessel Perforation
MAUDE report 17439992 ↗
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- 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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