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Beacon Tip Torcon NB G09469Recalls & reported problems

Cook Incorporated · Beacon Tip Torcon NB Advantage Catheter · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002094697), received between Nov 14, 2019 and Nov 14, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. 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 · FDA record ↗

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • Foreign Body In Patient1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 14, 2019Material Separation; Material Separation

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: Foreign Body In Patient; No Code Available

    MAUDE report 9323079 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.