Merit PursueRecalls & reported problems across all models
Merit Medical Systems, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Merit Pursue model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 5 models of Merit Pursue by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between May 30, 2023 and Sep 18, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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
Merit Pursue 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.
- Nov 6, 2023Open, Classified
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Z-0628-2024 · Root cause: Package design/selection · names 3 of these models · Recall details · FDA record ↗
Most reported Merit Pursue problems
Device problems
- Fracture2
- Device Contamination with Chemical or Other Material1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Merit Pursue models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Merit Pursue™ 00884450358733Catheter, percutaneous1 recall1 report
- Merit Pursue™ 00884450358566Catheter, percutaneous1 recall0 reports
- Merit Pursue™ 00884450358726Catheter, percutaneous1 recall0 reports
- Merit Pursue™ 00884450358528Catheter, percutaneous1 report
- Merit Pursue™ 00884450358719Catheter, percutaneous1 report
Recent Merit Pursue adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830069 ↗InjuryJan 30, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A RIGHT INFERIOR EPIGASTRIC ARTERY EMBOLIZATION, THE MICROCATHETER DETACHED WITHIN THE PATIENT BUT REMAINED ON THE GUIDEWIRE WITHIN THE GUIDECATHETER. THE DEVICE WAS SUCCESSFULLY REMOVED UNDER FLUOROSCOPIC GUIDANCE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607558 ↗InjuryMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A PAE PROCEDURE AND DURING AN OVER-THE-WIRE EXCHANGE, THE CATHETER WAS PULLED BACK AND THE RADIOPAQUE MARKER BROKE OFF THE TIP. THE PHYSICIAN LEFT IT IN THE PATIENT WITH NO PLANS TO REMOVE. THE PROCEDURE WAS FINISHED WITH A NEW DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 17027803 ↗
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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