Launcher™ LA7EBU35Recalls & reported problems
Medtronic, Inc. · CATHETER LA7EBU35 LA 7F 100CM EB35 · Class 2
All models of Launcher (64)
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 00763000908478), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Entrapment of Device1
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.
InjuryAug 20, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, INSERTION DIFFICULTIES WERE ENCOUNTERED. RESISTANCE WAS NOTED WHEN IT WAS ATTEMPTED TO ADVANCE THE STENT THROUGH THE NON-MEDTRONIC HEMOSTASIS VALVE. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE GUIDEWIRE FOR INSPECTION. NO ISSUES WERE NOTED AND THE STENT WAS RE-INSERTED WITHOUT ISSUE. THE LESION BEING TREATED WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 95% STENOSIS. THE LESION WAS PRE-DILATED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE STENT. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE STENT WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE STENT WAS DELIVERED TO THE LESION WITHOUT RESISTANCE. UPON INFLATING THE STENT BALLOON AT 14ATM, IT WAS NOTED THAT ONLY THE DISTAL ENDS OF THE STENT BALLOON APPEARED TO INFLATE. A LITTLE DOG BONING WAS NOTICED AT THE ENDS OF THE STENT BALLOON. BLOOD CAME BACK INTO THE SYRINGE WHEN NEGATIVE WAS PULLED. IT APPEARED THAT A STENT BALLOON LEAK OCCURRED. THE PHYSICIAN PULLED NEGATIVE AGAIN AND RE-AT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849038 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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