Flex-NeckRecalls & 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
1 open recall names at least one Flex-Neck 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
- 13
- Recalls
- 2
We found 11 models of Flex-Neck 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 Dec 5, 2017 and Aug 20, 2025 — classified as 13 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 reports).
2 FDA recall records 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
Flex-Neck 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 15, 2023Open, Classified
Product that was built for design verification testing was inadvertently distributed to customers.
Z-1352-2023 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗
- Sep 20, 2017Terminated
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
Z-1143-2018 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported Flex-Neck problems
Device problems
- Fracture12
- Material Separation5
- Fluid/Blood Leak3
- Adverse Event Without Identified Device or Use Problem2
- Crack2
- Material Perforation2
- Defective Device1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient3
- Peritonitis2
- Bacterial Infection1
- Extravasation1
- No Consequences Or Impact To Patient1
- Unspecified Infection1
Flex-Neck models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flex-Neck® 00884450170069CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall0 reports
- Flex-Neck® 00884450305850Catheter, peritoneal, long-term indwelling1 recall0 reports
- Flex-Neck® 00884450330166Catheter, peritoneal, long-term indwelling5 reports
- Flex-Neck® 00884450330241Catheter, peritoneal, long-term indwelling4 reports
- Flex-Neck® 00884450330067Catheter, peritoneal, long-term indwelling3 reports
- Flex-Neck® 00884450170199CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Flex-Neck® 00884450330159Catheter, peritoneal, long-term indwelling2 reports
- Flex-Neck® 00884450330210Catheter, peritoneal, long-term indwelling2 reports
- Flex-Neck® 00884450170298CATHETER, PERITONEAL, LONG-TERM INDWELLING1 report
- Flex-Neck® 00884450330203Catheter, peritoneal, long-term indwelling1 report
- Flex-Neck® 00884450375006Catheter, peritoneal, long-term indwelling1 report
Recent Flex-Neck adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 20, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES DURING THE CATHETER PLACEMENT PROCEDURE, THE CATHETER BROKE WHILE BEING PULLED THROUGH THE SUBCUTANEOUS TUNNEL. AS A RESULT, THE CATHETER WAS COMPLETELY REMOVED FROM THE PERITONEAL CAVITY. A REPLACEMENT PERITONEAL CATHETER OF THE SAME REFERENCE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22853847 ↗InjuryAug 5, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THE CATHETER WAS PLACED INTO THE PELVIS, AND WHEN THE CLINICIAN ATTEMPTED TO TUNNEL IT USING A METAL TUNNELER, WHILE EXITING THE SKIN THE CATHETER BROKE AND SEPARATED AT THE SECOND CUFF. THE CLINICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN PIECE OF THE CATHETER. A REPLACEMENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717355 ↗InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT, POST PROCEDURE, A PATIENT WAS BEING TREATED FOR A TUNNEL INFECTION AND EMPIRICALLY FOR PERITONITIS. A CVC WAS PLACED FOR TREATMENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Peritonitis
MAUDE report 20321802 ↗InjurySep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER ALLEGES THEY ARE HAVING ISSUES GETTING A CATHETER TO WORK. WHEN TRYING TO FLUSH WITH A SYRINGE, THEY REALIZED THAT THE FLUID SEEMED TO BE GOING INTO THE PATIENT'S TUNNEL, CREATING A BUBBLE BETWEEN INCISIONS IN THE CATHETER TUNNEL. THE PATIENT WAS STARTED ON ANTIBIOTICS FOR THE TUNNEL INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20300532 ↗InjurySep 19, 2024Obstruction of Flow; Defective Device; Migration; Obstruction of Flow; Defective Device; Migration
THE ACCOUNT ALLEGES THAT AN 82-YEAR-OLD MALE PATIENT PRESENTED IN A WHEELCHAIR CONSCIOUS AND ORIENTED. THE FUNCTIONALITY OF THE CATHETER WAS EVALUATED. AN ABDOMINAL X-RAY WAS PERFORMED SHOWING THE CATHETER HAD MIGRATED OUTSIDE THE PELVIC CAVITY. OUT OF POSITION. THE DRAINAGE CATHETER WAS TESTED, AND IT WAS FOUND THAT THE PD CATHETER WAS OCCLUDED AND WOULD NOT DRAIN. THE PHYSICIAN ORDERED THE PD CATHETER REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20261108 ↗MalfunctionDec 20, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
THE ACCOUNT ALLEGES THAT A PERITONEAL DIALYSIS PROCEDURE THE PHYSICIAN WAS ABLE TO PLACE THE CATHETER WITHOUT TROUBLE. ONCE THE PHYSICIAN WENT TO FLUSH THE CATHETER HE NOTICED IT WAS LEAKING. THE PHYSICIAN PLACED A PURSE STRING SUTURE AND TRIED AGAIN AND THE CATHETER CONTINUED TO LEAK. PHYSICIAN DECIDED TO REMOVE THE CATHETER AND PLACE ANOTHER CATHETER. ONCE THE PHYSICIAN REMOVED THE INITIAL CATHETER HE ATTEMPTED TO FLUSH IT AND THE CATHETER HAD A HOLE IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16016300 ↗MalfunctionAug 18, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
THE ACCOUNT ALLEGES THAT AFTER IMPLANTING A PERITONEAL DIALYSIS CATHETER IN A PEDIATRIC PATIENT THEY EXPERIENCED ISSUES WITH LEAKING. MULTIPLE ATTEMPTS WERE MADE TO MINIMIZE THE LEAKING; HOWEVER, THEY WERE UNSUCCESSFUL. CONTRAST STUDY SHOWED EXCESSIVE LEAKING TWO WEEKS AFTER IMPLANT. THE CATHETER WAS REMOVED AND SHOWED THAT THE CATHETER HAD BROKEN INTO TWO HALVES AND SEPARATED JUST BELOW THE CUFF. THE PATIENT WAS TREATED FOR EXIT SITE INFECTION WITH ORAL ANTIBIOTICS AND A NEW DEVICE WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15254803 ↗InjuryNov 30, 2021Fracture; Material Perforation; Fracture; Material Perforation
THE ACCOUNT ALLEGES THAT POST PD CATHETER PLACEMENT, THE CATHETER BECAME DAMAGED AND DETACHED WITHIN THE PATIENT. PLACEMENT WAS COMPLETED IN OCTOBER WITHOUT ANY CONCERNS. ADMISSION WAS NECESSARY 4 WEEKS POST IMPLANT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12902235 ↗MalfunctionSep 15, 2021Crack; Crack
THE ACCOUNT ALLEGES THAT AFTER SUCCESSFUL IMPLANT THE PD CATHETER STARTED SHOWING SIGNS OF FATIGUE. MICRO-CRACKS APPEARED AT THE HUB END OF THE CATHETER, OUTSIDE PATIENT BODY. LIQUID WAS NOTED LEAKING FROM THE CATHETER. THE HOSE HAS BEEN SHORTENED BY MEDICAL PROFESSIONALS 3 TIMES THUS REMOVING THE CRACKED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478341 ↗MalfunctionSep 15, 2021Crack; Crack
THE ACCOUNT ALLEGES THAT AFTER SUCCESSFUL IMPLANT THE PD CATHETER STARTED SHOWING SIGNS OF FATIGUE. MICRO-CRACKS APPEARED AT THE HUB END OF THE CATHETER, OUTSIDE PATIENT BODY. LIQUID WAS NOTED LEAKING FROM THE CATHETER. THE HOSE HAS BEEN SHORTENED BY MEDICAL PROFESSIONALS 3 TIMES THUS REMOVING THE CRACKED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478338 ↗InjuryMar 30, 2021Material Perforation; Material Perforation
THE ACCOUNT ALLEGES THAT DURING A DIALYSIS PROCEDURE, THE PERITONEAL DIALYSIS CATHETER TUBING WAS FOUND TO HAVE A SMALL PINHOLE IN THE END. THE MEDICAL STAFF CUT 5.5CM FROM THE EXIT POINT ON THE CATHETER TO REMOVE THE HOLE. THE PROCEDURE PROGRESSED NORMALLY. AN INFECTION "PERITONITIS" WAS IDENTIFIED AND THE PATIENT RECEIVED ANTIBIOTICS/MEDICAL INTERVENTION. THE PATIENT IS STILL USING THE PD CATHETER TODAY.
Patient problems: Bacterial Infection; Peritonitis
MAUDE report 11592455 ↗InjuryMar 29, 2021Material Puncture/Hole; Material Puncture/Hole
THE ACCOUNT ALLEGES THAT A PERITONEAL DIALYSIS CATHETER WAS IMPLANTED ON (B)(6) 2021, AND ON (B)(6) 2021 A SMALL HOLE WAS IDENTIFIED OUTSIDE THE CATHETER NEAR THE TRANSFER SET. THE CATHETER WAS TRIMMED TO REMOVE THE SMALL HOLE AND WAS THEN REINSERTED. ANTIBIOTICS WERE ADMINISTERED FOR 48 HOURS AS STANDARD PRECAUTIONS WARRANTED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11584328 ↗InjuryMar 17, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT POST-PLACEMENT OF A PERITONEAL DIALYSIS CATHETER ON (B)(6) 2021. THE CUSTOMERS HOMECARE NURSE REPORTED ON 02-23-2021 THAT THE CATHETER HAD DETACHED OUTSIDE THE PATIENT BODY AND A BAD ODOR AND DRAINAGE WAS NOTED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL IMMEDIATELY FOR A PD CATHETER REPLACEMENT. ANTIBIOTICS WERE ADMINISTERED FOR THIS PATIENT. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11509943 ↗InjuryMar 8, 2021Fracture; Detachment of Device or Device Component
FEMALE PATIENT IN HER 50¿S, WITH A NEWLY INSERTED PERITONEAL DIALYSIS CATHETER. RETURNED FOR REMOVAL OF THE PERITONEAL DIALYSIS CATHETER 5 DAYS LATER, BECAUSE THE CATHETER WAS FRACTURED, LEAVING ONLY THE INTERNAL SEGMENT. THE PHYSICIAN'S VISUAL INSPECTION IDENTIFIED THE FRACTURE WAS AT THE LEVEL OF THE SUPERFICIAL CATHETER CUFF. DAY 5: UNPLANNED PROCEDURE FOR REMOVAL OF CATHETER. DAY 5: CIPRO X 10 DAYS, FOLLOW UP VISIT 2 WEEKS AND NEW CATHETER TO BE INSERTED AFTER SITE IS HEALED. DAY 15: PER DR. - HE FEELS THERE PROBABLY WAS A DEFECT IN THE CATHETER BECAUSE WHEN LOOKING BACK AT THE PICTURES IT LOOKS LIKE THERE WAS SOME EXTRAVASATION WHICH HE THOUGHT ORIGINALLY WAS JUST FLOWING BACK THE TRACK.
Patient problems: Extravasation
MAUDE report 11434936 ↗MalfunctionOct 27, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERITONEAL DIALYSIS CATHETER PLACEMENT PROCEDURE ON AN INFANT, THE PERITONEAL DIALYSIS CATHETER BROKE WHILE PREPPING THE DEVICE FOR DEPLOYMENT. ANOTHER PD CATHETER WAS SUCCESSFULLY PREPPED AND PLACED WITHIN THE PATIENT. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10742916 ↗
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
- HeartSpan5 models · 10 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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