CorVocet™ 00884450476390Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884450476390), received between May 19, 2021 and Sep 25, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Insufficient Device Problem Information

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50906119 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE ACCOUNT ALLEGES THAT THE TIP OF THE CATHETER BROKE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180364 ↗
• MalfunctionJun 3, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING USE THE COAXIAL INTRODUCER COULD BE USED WITHOUT ANY PROBLEMS, BUT WHEN THE BIOPSY NEEDLE WAS ADVANCED INTO THE COAXIAL INTRODUCER FOR THE SECOND TIME, THERE WAS RESISTANCE. WHEN THE INTRODUCER AND BIOPSY NEEDLE WERE REMOVED FROM THE PATIENT BECAUSE OF THE RESISTANCE, THE INTRODUCER BROKE. THE TIP OF THE BROKEN INTRODUCER WAS IMMEDIATELY RETRIEVED BECAUSE THE BROKEN POSITION WAS OUTSIDE OF THE PATIENT'S BODY. THE PHYSICIAN MENTIONED THAT THE INTRODUCER WAS PRESSED AGAINST THE RIBS WITH A STRONG LOAD DUE TO RESPIRATORY FLUCTUATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136308 ↗
• MalfunctionJun 7, 2022Break; Firing Problem

  CORVOCET BIOPSY GUN CAME APART WHEN THE BIOPSY GUN WAS FIRED. NO KNOWN HARM TO PATIENT. 2ND INCIDENT IN 2 DAYS WITH SAME PRODUCT, SAME LOT NUMBER. REFER TO MEDSUN REPORT (B)(4) MANUFACTURER RESPONSE FOR INSTRUMENT, BIOPSY, CORVOCET¿ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14619004 ↗
• MalfunctionMay 27, 2022Break

  (B)(6) MALE WITH HISTORY OF RIGHT AXILLARY ADENOPATHY. PROCEDURE: CATSCAN GUIDED BIOPSY (CT/BX), LYMPH NODE RIGHT AXILLA. CORVOCET BIOPSY NEEDLE CAME APART WHEN FIRING TO TAKE A SAMPLE. NO KNOWN HARM TO PATIENT, ANOTHER CORVOCET USED SUCCESSFULLY. MANUFACTURER RESPONSE FOR INSTRUMENT, BIOPSY, CORVOCET¿ (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521638 ↗
• MalfunctionMar 14, 2022Connection Problem

  UPON INSPECTING THE BIOPSY NEEDLE FOR PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE COAXIAL WAS NOT GLUED PROPERLY AND WOULD NOT STAY ATTACHED TO THE HUB . IT WAS NOT USED ON A PATIENT. MANUFACTURER RESPONSE FOR INSTRUMENT, BIOPSY, CORVOCET¿ (PER SITE REPORTER): WILL INVESTIGATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13756922 ↗
• InjuryJul 15, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A BIOPSY PROCEDURE, THE TIP OF THE BIOPSY NEEDLE BECAME STUCK IN THE PATIENT. WHEN THE CLINICIAN TRIED TO REMOVE THE DEVICE, THE NEEDLE DETACHED WITHIN THE PATIENT. THE CLINICIAN WAS UNSUCCESSFUL IN ATTEMPTS TO REMOVE THE FOREIGN BODY FROM THE PATIENT. THE PATIENT WAS REFERRED TO ORTHOPEDIC TRAUMA TEAM FOR INTERVENTIONAL SURGERY FOR FOREIGN BODY REMOVAL. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174196 ↗
• MalfunctionMay 19, 2021Retraction Problem

  PATIENT WITH HISTORY OF ESOPHAGEAL CANCER UNDERWENT A CT LIVER BIOPSY WITH A CORVOCET" 18 GAUGE 15CM NEEDLE (CORVOCET" SOFT-TISSUE BIOPSY PROCEDURE KIT) . THE NEEDLE FIRED AND ENGAGED IN USE, BUT WHEN IT WAS RETRACTED, THERE WAS NO SPECIMEN. IT WAS ATTEMPTED SEVERAL TIMES WITH THE SAME RESULTS. NEEDLE WAS REMOVED AND ANOTHER ONE USED SUCCESSFULLY. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847651 ↗