CorVocet™ 00884450476475Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of CorVocet (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450476475), received between Nov 8, 2021 and Jan 20, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- 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
Device problems
- Break1
- Failure to Fire1
- Fracture1
- Material Fragmentation1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Break; Fracture; Material Fragmentation; Material Separation
THE ACCOUNT ALLEGES THAT THE TOP PART OF THE BIOPSY NEEDLE IS LOOSE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24119186 ↗MalfunctionJan 12, 2026
THE TOP PART OF THE BIOPSY NEEDLE IS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032019 ↗MalfunctionNov 8, 2021Failure to Fire
PATIENT WITH HISTORY OF RIGHT LUNG NODULE WAS ADMITTED FOR A CT SCAN-GUIDED BIOPSY OF RIGHT LUNG. THE NEEDLE OF THE CORVOCET BIOPSY SYSTEM WAS CHECKED PRIOR TO USING THE DEVICE. THE NEEDLE DID NOT FIRE AS IT SHOULD HAVE. NEEDLE WAS NOT USED ON PATIENT. A NEW NEEDLE WAS USED FOR THE CASE. NO KNOWN HARM TO PATIENT.
Patient problems: Insufficient Information
MAUDE report 12770132 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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