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Cook G08286Recalls & reported problems

Cook Incorporated · Liver Access and Biopsy Needle · Class 2

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 00827002082861), received between Oct 27, 2016 and Oct 27, 2016 — classified as 1 injury.

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

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • InjuryOct 27, 2016Material Separation; Material Separation

    IT WAS REPORTED DURING A TRANSJUGULAR BIOPSY (BX) PROCEDURE THE 7FR SHEATH FRACTURED AT THE DISTAL TIP WHILE GAINING ACCESS THROUGH THE RIGHT HEPATIC VEIN IN THE LIVER OF A TORTUOUS ANATOMY. (180334-2016-01148). THE FRACTURE OF THE SHEATH LED TO BOTH THE MEMORY POLYP BASKETS (MPB) AND ANOTHER MANUFACTURERS GLIDE CATHETER DISTAL TIPS BEING SHEARED OFF AND REMAINING IN THE PATIENT, THE GLIDE CATHETER WAS RETRIEVED USING A SNARE. THE COOK MPB WAS LOCATED IN THE PULMONARY ARTERY AND UNABLE TO BE RETRIEVED. (1820334-2016-01149).

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6061610 ↗

Other Biopsy needle devices

All Biopsy needle devices →

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