Merit MaestroRecalls & reported problems across all models
Merit Medical Systems, Inc. · 27 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 Maestro model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 27 models of Merit Maestro by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2020 and May 21, 2026 — classified as 3 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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 Maestro 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-0627-2024 · Root cause: Package design/selection · names 23 of these models · Recall details · FDA record ↗
Most reported Merit Maestro problems
Device problems
- Fracture6
- Material Separation6
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Merit Maestro models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Merit Maestro® 00884450357958Catheter, continuous flush1 recall1 report
- Merit Maestro® 00884450358139Catheter, continuous flush1 recall1 report
- Merit Maestro® 00884450358160Catheter, continuous flush1 recall1 report
- Merit Maestro® 00884450038383Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335215Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335239Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335246Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335253Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335260Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335277Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335284Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450335291Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450357903Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450357910Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450357927Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450357934Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450357965Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450357989Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450358016Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450358023Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450358030Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450358047Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450358085Catheter, continuous flush1 recall0 reports
- Merit Maestro® 00884450358153Catheter, continuous flush2 reports
- Merit Maestro® 00884450013915Catheter, continuous flush1 report
- Merit Maestro® 00884450038451Catheter, continuous flush1 report
- Merit Maestro® 00884450038468Catheter, continuous flush1 report
Recent Merit Maestro adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Fracture
CUSTOMER ALLEGED THE TIP OF CATHETER WAS DETACHED DURING A TACE (TRANSARTERIAL CHEMOEMBOLIZATION) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243531 ↗MalfunctionDec 3, 2025Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING USE THE CATHETER DETACHED FROM THE HUB. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708497 ↗InjuryNov 1, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE MICROCATHETER DETACHED FROM THE REST OF THE CATHETER WITHIN THE PATIENT. THE DEVICE WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049091 ↗InjuryJul 13, 2022Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A CELIAC ARTERY EMBOLIZATION WHILE ATTEMPTING TO MANIPULATE THE MICROCATHETER WITHIN THE PATIENT, THE RADIOPAQUE MARKER BAND DETACHED WITHIN THE PATIENT'S TORTUOUS ANATOMY. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. THE EMBOLIZATION PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15009070 ↗MalfunctionDec 8, 2021Fracture; Fracture
THE ACCOUNT ALLEGES DURING A FIBROIDS EMBOLIZATION PROCEDURE, THE RADIPAQUE TIP OF THE MICROCATHETER CAME LOOSE OUTSIDE THE BODY OF THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW UNIT. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12960602 ↗MalfunctionOct 20, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PROCEDURE THE MARKER BAND ON A 2.9F MICRO CATHETER DETACHED WITHIN A UFE CATHETER. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE MARKER BAND TOGETHER WITH THE UFE CATHETER RESULTING IN NO FOREIGN BODY INTRODUCTION WITHIN THE PATIENT. ANOTHER CATHETER WAS PREPPED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12665599 ↗MalfunctionJun 4, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING A LEFT UTERINE FIBROID EMBOLIZATION [UFE] PROCEDURE ON (B)(6) 2020, THE MICROCATHETERS RADIOPAQUE MARKER BAND DETACHED WITHIN A PATIENT. THE PHYSICIAN HAD ACQUIRED RIGHT RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND A 5F GUIDE CATHETER. DURING MICROCATHETER MANIPULATIONS OVER THE WIRE WITHIN THE PATIENT'S LEFT UTERINE ARTERY THE MARKER BAND DETACHED. THE PHYSICIAN NOTED THE PATIENT'S ANATOMY WAS TORTUOUS AND VERY DIFFICULT TO NAVIGATE. THE RADIOPAQUE BAND BECAME EMBEDDED WITHIN THE PATIENT'S VASCULATURE SYSTEM THAT WAS FEEDING THE FIBROID. THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY ACTING AS AN EMBOLIC WITHIN THE PATIENT. THE EMBOLIZATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THE OUTPATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME WITHOUT FURTHER CONSEQUENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10119506 ↗InjuryFeb 14, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL INTRAVASCULAR PROCEDURE, THE RADIOPAQUE MARKER BAND DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS, AND WHILE MANIPULATING A MICRO CATHETER THROUGH A RUC CATHETER, THE MARKER BAND DETACHED FROM THE CATHETER YET REMAINED ON THE GUIDE WIRE. THE MARKER BAND WAS SUCCESSFULLY CAPTURED AND REMOVED WITH THE ASSISTANCE OF A SMALL PERIPHERAL BALLOON. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INJURIES OR CONSEQUENCES TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 9712680 ↗
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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