Adelante Magnum ASM016030Recalls & reported problems
Oscor Inc. · Introducer Set with Hemostatic Valve, 16F · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885672004736), received between Feb 8, 2019 and Feb 22, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Calcium Deposits/Calcification1
- Stenosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2019Break; Break
THE PATIENT WAS SCHEDULED FOR A CARADIC SURGERY PROCEDURE (TRANSCATHETER AORTIC VALVE REPLACEMENT), AND DURING THE PROCEDURE THE SHEATH WAS BROKEN WHILE EXCHANGING OUT THE SHEATH. THIS BROKE OUTSIDE THE PATIENT'S BODY AND DID NOT NEGATIVELY IMPACT THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Calcium Deposits/Calcification; No Known Impact Or Consequence To Patient; Stenosis
MAUDE report 8363869 ↗MalfunctionFeb 22, 2019Break; Break
PATIENT WAS SCHEDULED FOR A TAVI PROCEDURE, AND DURING AORTIC VALVE REPLACEMENT THE TIP BROKE OFF OF ADELANTE MAGNUM INTRODUCER SHEATH INSIDE THE PATIENT. ONCE THIS OCCURRED THE PHYSICIAN RETRIEVED A NEW DEVICE, AND THE ISSUE WAS RESOLVED; THE PROCEDURE WAS DELAYED A MOMENT TO RETRIEVE ANOTHER DEVICE. IT WAS REPORTED THE PATIENT WAS NOT IMPACTED AND NO ADVERSE PATIENT EFFECT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8363740 ↗MalfunctionFeb 13, 2019Break
SHEATH WAS BROKEN WHILE EXCHANGING OUT THE SHEATH. THIS BROKE OUTSIDE OF THE PATIENT'S BODY AND DID NOT NEGATIVELY IMPACT THIS PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8334835 ↗MalfunctionFeb 8, 2019Detachment of Device or Device Component
DURING AORTIC VALVE REPLACEMENT TIP BROKE OFF OF ADELANTE MAGNUM INTRODUCER SHEATH. THE PATIENT WAS NOT NEGATIVELY HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8319797 ↗
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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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