CorVocet™ 00884450373828Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of CorVocet (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450373828), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 injury.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemoptysis1
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
A Merit employee conducted a CER literature search (Ortmans 2024) for the Corvocet Biopsy System. This study evaluated 240 patients. 215 patients experienced no major complications. 23 patients experienced pneumothorax requiring chest tube placement and hospitalization; 2 patients experienced events of hemoptysis requiring hospitalization with one patient requiring oxygen therapy and another patient requiring endotracheal intubation. Reference to the study: Quant Imaging Med Surg 2024;14(9):6830-6842. doi: 10.21037/qims-23-500.
Patient problems: Hemoptysis; Pneumothorax
MAUDE report 50934781 ↗
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- 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
- 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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