One-StepRecalls & reported problems across all models
Merit Medical Systems, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 11 models of One-Step by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2021 and Sep 8, 2026 — classified as 10 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (84 reports).
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
Most reported One-Step problems
Device problems
- Fluid/Blood Leak84
- Material Separation7
- Fracture6
- Adverse Event Without Identified Device or Use Problem1
- Air/Gas in Device1
- Break1
- Gas/Air Leak1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Foreign Body In Patient4
- Abdominal Pain2
- Chills2
- Fever2
- Pneumothorax2
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
One-Step models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- One-Step™ 00884450092712CATHETER, IRRIGATION30 reports
- One-Step™ 00884450092644CATHETER, IRRIGATION29 reports
- One-Step™ 00884450537336CATHETER, IRRIGATION19 reports
- One-Step™ 00884450092606CATHETER, IRRIGATION4 reports
- One-Step™ 00884450092750CATHETER, IRRIGATION4 reports
- One-Step™ 00884450032893CATHETER, IRRIGATION3 reports
- One-Step™ 00884450012062CATHETER, IRRIGATION2 reports
- One-Step™ 00884450012079CATHETER, IRRIGATION2 reports
- One-Step™ 00884450092538CATHETER, IRRIGATION2 reports
- One-Step™ 00884450012055CATHETER, IRRIGATION1 report
- One-Step™ 00884450536391CATHETER, IRRIGATION1 report
Recent One-Step adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677566 ↗MalfunctionMar 12, 2026Fracture
THE ACCOUNT ALLEGES THAT DURING A PLEURAL PUNCTURE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PUNCTURE CATHETER BROKE DURING USE. A WHITE PLASTIC COMPONENT REMAINED WITHIN THE CHEST WALL BUT WAS SUCCESSFULLY RETRIEVED DUE TO A SMALL VISIBLE FRAGMENT REMAINING OUTSIDE THE BODY. THE PHYSICIAN REPORTED THAT IF THE FRAGMENT HAD NOT BEEN VISIBLE, SURGICAL INTERVENTION WOULD HAVE BEEN REQUIRED TO RETRIEVE THE RETAINED COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583315 ↗MalfunctionMar 4, 2026Gas/Air Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE CATHETER IS NOT FUNCTIONING APPROPRIATELY AND PULLS AIR INTO THE PATIENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507102 ↗MalfunctionOct 15, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING PREPARATION OF A CENTESIS PROCEDURE, THE CATHETER BROKE AT THE HUB. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292622 ↗InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN EMPLOYEE CONDUCTED A PMCF REVIEW FOR A DRAINAGE CATHETER. THE DRAINAGE CATHETER WAS USED TO TREAT A MALE PATIENT WITH A PLEURAL EFFUSION. THE PRIMARY USAGE OF THE DEVICE WAS TO FACILITATE PERCUTANEOUS DRAINAGE OF FLUIDS. THE LITERATURE REVIEWED ALLEGES THAT DURING THE USE OF THE DRAINAGE CENTESIS CATHETER A PLEURAL EFFUSION THE PATIENT ACQUIRED A PNEUMOTHORAX. NO ADDITIONAL INFO WAS RECEIVED FOR THE LITERATURE REVIEW. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: Pneumothorax
MAUDE report 21471484 ↗MalfunctionOct 18, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A THORACENTESIS PROCEDURE, AFTER GAINING ACCESS AND USING A 60ML SYRINGE TO PULL A SAMPLE, THE VALVE CAME OFF WHEN REMOVING THE SYRINGE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17957721 ↗InjuryOct 2, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT AN ADULT FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT WITH FEVER, CHILLS, AND RIGHT LOWER QUADRANT ABDOMINAL PAIN POST RIGHT FEMORAL AND UMBILICAL HERNIA REPAIR WITH MESH 17 MONTHS AGO. THREE WEEKS PRIOR TO ARRIVAL TO EMERGENCY DEPARTMENT, THE PATIENT EXPERIENCED RECURRENT RIGHT INGUINAL FLUID COLLECTION AND REQUIRED ASPIRATION AND DRAIN IN INTERVENTIONAL RADIOLOGY. THE DRAIN WAS REMOVED 4 DAYS PRIOR TO EMERGENCY DEPARTMENT ARRIVAL. CT IMAGING SHOWED INCREASED SIZE OF FLUID COLLECTION, AS WELL AS RETAINED FOREIGN BODY MEASURING 1.1 CENTIMETERS. THE PATIENT UNDERWENT ROBOT-ASSISTED FOREIGN BODY REMOVAL AND ABCESS DRAINAGE.
Patient problems: Abdominal Pain; Chills; Fever; Foreign Body In Patient
MAUDE report 17857653 ↗MalfunctionSep 29, 2023
THIS IS AN ADULT FEMALE WITH HISTORY OF HERNIA REPAIR WHO PRESENTED TO EMERGENCY DEPARTMENT (ED) WITH FEVER, CHILLS, AND ABDOMINAL PAIN. PATIENT IS STATUS POST RIGHT FEMORAL AND UMBILICAL HERNIA REPAIR WITH MESH 17 MONTHS AGO. POST-SURGERY, THE PATIENT EXPERIENCED RECURRENT RIGHT INGUINAL FLUID COLLECTIONS AND HAD AN ASPIRATION AND DRAIN PLACED IN INTERVENTIONAL RADIOLOGY 3 WEEKS BEFORE ARRIVAL TO ED. THE DRAIN WAS REMOVED AFTER 2.5 WEEKS AND SHE DEVELOPED FEVER, CHILLS, AND RIGHT LOWER QUADRANT (RLQ) ABDOMINAL PAIN 4 DAYS POST REMOVAL. COMPUTERIZED TOMOGRAPHY (CT) IMAGING SHOWED INCREASED SIZE OF THE FLUID COLLECTION, AS WELL AS A SMALL RETAINED FOREIGN BODY MEASURING 1.1 CM. ULTRASOUND IMAGING 2 DAYS LATER REVEALED SIMILAR FINDINGS: ¿9 MM ECHOGENIC, TUBULAR STRUCTURE IN THE RIGHT LOWER QUADRANT COLLECTION. THIS COULD REPRESENT A FRAGMENT OF DRAINAGE CATHETER.¿ GENERAL SURGERY CONSULTED TO EVALUATE THE PATIENT. THE PATIENT UNDERWENT ROBOT-ASSISTED FOREIGN BODY REMOVAL AND ABSCESS DRAINAGE.
Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Fever; Foreign Body In Patient
MAUDE report 17842440 ↗MalfunctionFeb 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16415035 ↗MalfunctionJan 9, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE DURING A THORACENTESIS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16127817 ↗MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15844342 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642724 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642716 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642710 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642704 ↗
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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