ProGuideRecalls & reported problems across all models
Merit Medical Systems, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ProGuide model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 14 models of ProGuide by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2020 and Jul 29, 2025 — classified as 4 injuries, 17 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
ProGuide 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.
- Feb 13, 2026Open, Classified
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Z-1576-2026 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗
Most reported ProGuide problems
Device problems
- Fracture10
- Fluid/Blood Leak6
- Material Separation4
- Crack2
- Material Integrity Problem2
- Difficult to Insert1
- Insufficient Flow or Under Infusion1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient3
- Failure of Implant2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
- Reduced Blood Flow1
ProGuide models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ProGuide™ 00884450697917Catheter, hemodialysis, implanted1 recall1 report
- ProGuide™ 00884450697948Catheter, hemodialysis, implanted1 recall1 report
- ProGuide™ 00884450697894Catheter, hemodialysis, implanted1 recall0 reports
- ProGuide™ 00884450697900Catheter, hemodialysis, implanted1 recall0 reports
- ProGuide™ 00884450697924Catheter, hemodialysis, implanted1 recall0 reports
- ProGuide™ CCatheter, Hemodialysis, Implanted1 recall0 reports
- ProGuide™ CCatheter, hemodialysis, implanted1 recall0 reports
- ProGuide™ 00884450023426Catheter, hemodialysis, implanted7 reports
- ProGuide™ 00884450027875Catheter, hemodialysis, implanted3 reports
- ProGuide™ 00884450012536Catheter, hemodialysis, implanted2 reports
- ProGuide™ 00884450029732Catheter, hemodialysis, implanted2 reports
- ProGuide™ 00884450096413Catheter, hemodialysis, implanted2 reports
- ProGuide™ 00884450697221Catheter, hemodialysis, implanted2 reports
- ProGuide™ 00884450117347Catheter, hemodialysis, implanted1 report
Recent ProGuide adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 29, 2025Difficult to Insert; Difficult to Insert
THE ACCOUNT ALLEGES DURING THE PROCEDURE FOR IMPLANTATION OF A PERMANENT CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT EXPERIENCED A COMPLICATION RELATED TO THE MEDICAL DEVICE. AS A RESULT, THE PROCEDURE WAS SUSPENDED AND THE CATHETER WAS REMOVED. DUE TO THE COMPLEXITY OF THE VASCULAR ACCESS, THE PATIENT WAS URGENTLY REFERRED TO INTERVENTIONAL RADIOLOGY.
Patient problems: Failure of Implant
MAUDE report 22647402 ↗InjuryAug 21, 2024Fracture; Fracture
THE CUSTOMER ALLEGES THAT THE CATHETER DETACHED WITHIN THE PATIENT POST-PROCEDURE. A CHEST X-RAY WAS PERFORMED CONFIRMING CATHETER DETACHMENT AT THE LEVEL OF THE LEFT EDGE OF THE CARDIAC SILHOUETTE, HOSPITALIZING THE PATIENT FOR TWO DAYS UNTIL HIS HEALTH IMPROVED. THE PATIENT WAS TAKEN FOR FOREIGN BODY REMOVAL AND INSERTION OF A NEW DIALYSIS CATHETER ON (B)(6) 2024. ON (B)(6) 2024 HE WAS DISCHARGED WITH FAVORABLE EVOLUTION.
Patient problems: Foreign Body In Patient
MAUDE report 20015451 ↗MalfunctionAug 15, 2024Pressure Problem; Pressure Problem
THE ACCOUNT ALLEGES THAT A FEMORAL HEMODIALYSIS CATHETER WAS IMPLANTED IN THE PATIENT. THE ACCOUNT ALLEGES THAT THE CATHETER IS NOT ALLOWING GOOD FLOW PRESSURES DURING THE DIALYSIS PROCEDURE EXTENDING DIALYSIS TIME FOR THE PATIENT. A NEW IJ CATHETER WAS PLACED AND THE PATIENT EXPERIENCED THE SAME LOW FLOW VALUES AGAIN. THE PATIENT RETURNED TO THE HOSPITAL FOR ANOTHER HEMODIALYSIS CATHETER THE NEXT DAY. THE HD CATHETER WAS EXCHANGED AND WAS FOUND TO BE OPERATING CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19997522 ↗MalfunctionAug 14, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
THE ACCOUNT ALLEGES THAT THE HEMODIALYSIS CATHETER WAS NOT PROVIDING GOOD FLOW. THE NEXT DAY THE CATHETER WAS CHANGED FOR A NEW ONE IN THE RIGHT JUGULAR AND IT IS CURRENTLY REPORTED TO BE FUNCTIONING CORRECTLY.
Patient problems: Reduced Blood Flow
MAUDE report 19981727 ↗MalfunctionJul 24, 2024Crack; Crack
THE ACCOUNT ALLEGES THAT THE CATHETER HUB CRACKED 8 MONTHS AFTER THE DIALYSIS CATHETER WAS IMPLANTED. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19821263 ↗MalfunctionMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THE PHYSICIAN TRIED TO REMOVE THE SHEATH AFTER HE SPLIT THE CATHETER AND THE HUBS BROKE OFF WITH PART OF THE SHEATH ATTACHED. THE REST OF THE SHEATH AND OTHER SIDE OF THE HUB REMAINED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO GET THE SHEATH OUT BY CAREFULLY CUTTING THE SHEATH WITH SCISSORS AS HE REMOVED SMALL AMOUNTS AT A TIME. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17027365 ↗InjuryMay 23, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A DIALYSIS PROCEDURE ON A 45YO MALE PATIENT, A LONG-TERM HEMODIALYSIS CATHETER IN THE PATIENT'S RIGHT NECK WAS FIXED IN PLACE. THE CATHETER END WAS USED TO WITHDRAW FLUID SMOOTHLY FOR PREPARATION OF DIALYSIS. THERE WAS A NOTED CRACK IN THE THREADS OPENING AT THE ARTERIAL END, ABOUT 1CM. THE WITHDRAWAL OF FLUID WAS SMOOTH AND ACCOMPANIED BY CONTINUOUS AIR BUBBLES. THIS WAS IMMEDIATELY REPORTED TO THE PHYSICIAN ON DUTY. THE PHYSICIAN WANTED TO SEAL THE PATIENT'S TUBE FOR CONTINUED USE AND EVENTUALLY REPLACE THE CATHETER WHEN POSSIBLE. NO INJURY OF THE PATIENT TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16985924 ↗MalfunctionMay 17, 2023Material Puncture/Hole; Material Puncture/Hole
THE ACCOUNT ALLEGES THAT DURING ECMO PROCEDURE, A CRACK WAS NOTED IN THE VENOUS PORT ALLOWING AIR INTO THE DIALYSIS CATHETER. MINOR BLOOD LOSS WAS ALSO NOTED. THE DEVICE WAS EXCHANGED FOR A NEW ONE WITH NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16946569 ↗MalfunctionApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DIALYSIS CATHETER LEAKED POST PROCEDURE FROM THE HUB. THE CATHETER WAS INSERTED 6 MONTHS AGO. THE CATHETER WAS REMOVED AND A NEW ONE IMPLANTED. NO INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16717437 ↗MalfunctionFeb 16, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
THE ACCOUNT ALLEGES AFTER IMPLANTATION OF A PROGUIDE DIALYSIS CATHETER, THE CATHETER WAS FOUND TO BE CRACKED AND LEAKED BLOOD WHEN TRYING TO ACCESS THE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16386488 ↗MalfunctionFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DIALYSIS CATHETER WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. DURING THE PATIENT'S DIALYSIS PROCEDURE, THE MEDICAL STAFF NOTED THAT THE DIALYSIS CATHETERS HUB WAS CRACKED AND LEAKING BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16383295 ↗MalfunctionFeb 9, 2023Fracture; Fracture
THE ACCOUNT ALLEGES THAT POST PROCEDURE THE HUB OF THE CATHETER WAS CRACKED. NO PATIENT INJURY TO REPORT. A NEW DEVICE WAS PLACED FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16345070 ↗MalfunctionFeb 7, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE HUB ON THE DIALYSIS CATHETER CRACKED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16314119 ↗MalfunctionFeb 7, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE HUB ON THE DIALYSIS CATHETER CRACKED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16314086 ↗MalfunctionFeb 7, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE HUB ON THE DIALYSIS CATHETER CRACKED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16314080 ↗
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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