Beacon Tip Torcon NB G11457Recalls & reported problems
Cook Incorporated · Beacon Tip Torcon NB Advantage Catheter · Class 2
All models of Beacon Tip Torcon NB (69)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002114579), received between Sep 24, 2019 and Jul 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 15, 2025Open, Classified
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Z-1902-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2025Break; Break
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER BROKE OFF IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22522311 ↗MalfunctionSep 24, 2019Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9109400 ↗
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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 · each recall links to the FDA recall notice
- 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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