CorVocetRecalls & reported problems across all models
Merit Medical Systems, Inc. · 62 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CorVocet model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 1
We found 62 models of CorVocet by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2020 and Sep 29, 2026 — classified as 9 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
CorVocet recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 3, 2022Open, 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 · names 60 of these models · Recall details · FDA record ↗
Most reported CorVocet problems
Device problems
- Fracture10
- Material Separation6
- Break4
- Failure to Fire3
- Fluid/Blood Leak2
- Material Fragmentation2
- Activation, Positioning or Separation Problem1
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient4
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- Exposure to Body Fluids1
- Hemoptysis1
- Hemorrhage/Blood Loss/Bleeding1
- Needle Stick/Puncture1
CorVocet models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CorVocet™ 00884450476390INSTRUMENT, BIOPSY1 recall8 reports
- CorVocet™ 00884450316672INSTRUMENT, BIOPSY1 recall3 reports
- CorVocet™ 00884450476475INSTRUMENT, BIOPSY1 recall3 reports
- CorVocet™ 00884450316412INSTRUMENT, BIOPSY1 recall2 reports
- CorVocet™ 00884450476352INSTRUMENT, BIOPSY1 recall2 reports
- CorVocet™ 00884450476406INSTRUMENT, BIOPSY1 recall2 reports
- CorVocet™ 00884450316634INSTRUMENT, BIOPSY1 recall1 report
- CorVocet™ 00884450316641INSTRUMENT, BIOPSY1 recall1 report
- CorVocet™ 00884450476383INSTRUMENT, BIOPSY1 recall1 report
- CorVocet™ 00884450477656INSTRUMENT, BIOPSY1 recall1 report
- CorVocet™ 00884450477663INSTRUMENT, BIOPSY1 recall1 report
- CorVocet™ 00884450316405INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316429INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316436INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316443INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316450INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316467INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316528INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316535INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316542INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316559INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316566INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316580INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316597INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316603INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316610INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316627INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316658INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316665INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316689INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316740INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316757INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316771INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316788INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450316801INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476116INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476192INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476222INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476253INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476284INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476314INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476338INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476345INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476369INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476376INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476413INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476437INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476451INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450476468INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477496INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477526INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477557INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477571INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477595INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477601INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477618INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477625INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477632INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477649INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450477670INSTRUMENT, BIOPSY1 recall0 reports
- CorVocet™ 00884450333327Biopsy needle1 report
- CorVocet™ 00884450373828INSTRUMENT, BIOPSY1 report
Recent CorVocet adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 25, 2026Insufficient Device Problem Information
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50906119 ↗MalfunctionSep 8, 2026Loss of or Failure to Bond; Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670657 ↗MalfunctionSep 8, 2026Difficult to Remove; Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670656 ↗MalfunctionJan 28, 2026Fracture; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO CAPTURE A BIOPSY SAMPLE, THE NEEDLE DETACHED COMPLETELY. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199365 ↗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 ↗MalfunctionJan 6, 2026Fracture
THE ACCOUNT ALLEGES THAT THE NEEDLE OF THE DEVICE DETACHED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980239 ↗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 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 ↗InjuryFeb 28, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN IMAGE-GUIDED BIOPSY PROCEDURE, THE COAXIAL INTRODUCER DETACHED NEXT TO THE PATIENT'S SPINE. AN INTERVENTIONAL RADIOLOGIST SUCCESSFULLY REMOVED THE DEVICE FROM THE PATIENT VIA A CUT-DOWN TECHNIQUE AND A PAIR OF FORCEPS. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456658 ↗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 ↗InjuryMay 11, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A KIDNEY BIOPSY PROCEDURE, THE BIOPSY DEVICE DETACHED AT THE BEVEL OF THE NEEDLE AND THE TIP REMAINED WITHIN THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR REMOVAL OF THE DETACHED PORTION OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14365493 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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