CorVocet™ 00884450476406Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450476406), received between Jun 29, 2021 and Jul 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
- Fluid/Blood Leak1
Patient problems
- Exposure to Body Fluids1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT WHEN DOING BIOPSIES WITH THE INTRODUCER, THEY NOTICED REFLUX OF BLOOD THROUGH THE HUB OF THE INTRODUCER NEEDLE. A PATIENT HAD FLUID SPATTER IN HIS EYES FOLLOWING BIOPSY OF A PELVIC MASS.
Patient problems: Exposure to Body Fluids
MAUDE report 22522718 ↗MalfunctionJun 29, 2021Activation, Positioning or Separation Problem
AS REPORTED BY STAFF, "BIOPSY DEVICE APPEARED TO FIRE BUT ONLY BLOOD WAS ON THE NEEDLE INSTEAD OF A 20 MM TISSUE SPECIMEN." ASSOCIATE REPORTING INDICATED TWO DEVICES FAILED BOTH WITH THE SAME LOT NUMBER (BEING REPORTED) REQUIRING A THIRD DEVICE TO BE OPENED AND USED TO COMPLETE THE PROCEDURE (DEVICE LOT NUMBER THAT WAS SUCCESSFULLY USED IS UNKNOWN).
Patient problems: Insufficient Information
MAUDE report 12083492 ↗
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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