Flex-Neck® 00884450330210Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450330210), received between Mar 8, 2021 and Mar 17, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Extravasation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
Other Catheter, peritoneal, long-term indwelling devices
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- Argyle 8888415604Mozarc Medical US LLC · Catheter, peritoneal, long-term indwelling48 reports
- Argyle 8888423103Mozarc Medical US LLC · Catheter, Peritoneal, Long-Term Indwelling42 reports
- Argyle 8888411405Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING33 reports
- Argyle 8888413807Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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