CorVocet™ 00884450316634Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450316634), received between Jun 22, 2020 and Jun 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. Aug 3, 2022Open, Classified

   Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

   Z-0137-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 22, 2020Material Twisted/Bent

  MIDDLE-AGED FEMALE WITH HISTORY OF DIABETES, EPILEPSY, PROTEINURIA AND CHRONIC KIDNEY DISEASE. PROCEDURE IN INTERVENTIONAL RADIOLOGY CT- BIOPSY RENAL CORE. UPON OPENING THE BIOPSY NEEDLE, DR. SAW THAT THE VERY END TIP OF THE BIOPSY NEEDLE WAS BENT OUTWARD. HE ATTEMPTED TO CHECK THIS NEEDLE FOR ATTEMPTED USE BUT OPENED A 2ND NEEDLE FOR USE. NO HARM DONE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178374 ↗