CorVocet™ 00884450316672Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450316672), received between Jun 22, 2020 and Jul 15, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (2 reports).

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 18, 2026.

Recalls naming this device

1. Aug 3, 2022Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2020Failure to Fire

  ELDERLY PATIENT WITH HISTORY OF LEFT UPPER LOBE NODULE, HAVING A CT FOR BIOPSY OF LEFT LUNG. BIOPSY DEVICE WAS OPENED FOR BIOPSY AND UPON ATTEMPTING TO FIRE THE DEVICE THE NEEDLE WOULD NOT FIRE. NO HARM WAS DONE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277544 ↗
• MalfunctionJul 15, 2020Failure to Fire

  ELDERLY MALE PATIENT. 20X15CM CORVOCET NEEDLE BIOPSY SYSTEM WAS OPENED AND TESTED PRIOR TO USE AND THE GUN WOULD NOT FIRE (NOT USED ON PATIENT). A SECOND NEEDLE WAS OPENED AND TESTED AND UPON ATTEMPTING TO USE IT, THE NEEDLE WAS NOT FIRING CORRECTLY AND WOULD NOT RELEASE THE SMALL CORE SAMPLE THAT WAS TAKEN. NO HARM WAS DONE TO THE PATIENT. AFTER INVESTIGATION, BOTH PRODUCTS HAD THE SAME LOT#. THERE WAS A 3RD REPORT DONE A FEW DAYS LATER FOR THE SAME PRODUCT. IT ALSO HAD THE SAME LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275537 ↗
• MalfunctionJun 22, 2020Defective Device

  ELDERLY FEMALE WITH HISTORY OF LEFT LUNG NODULE. UNDERGOING PROCEDURE FOR BIOPSY LEFT LOWER LOBE LUNG. WHEN THE BIOPSY NEEDLE PACKAGING WAS OPENED THE BLUNT PART OF THE COAXIAL WAS NOT GLUED PROPERLY TO THE CLEAR HUB. ANOTHER NEEDLE WAS OPENED AND USE ON PATIENT. THE DEFECTIVE NEEDLE WAS NEVER USED ON THE PATIENT AND NO HARM WAS DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178373 ↗