HydroMID Catheter MID-141CMRecalls & reported problems
Access Vascular, Inc. · Midline 4Fr Single Lumen Marked Catheter · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850030354365), received between Jan 6, 2026 and Jun 19, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
- Insufficient Device Problem Information4
Patient problems
- Thrombosis/Thrombus3
- No Clinical Signs, Symptoms or Conditions2
- Obstruction/Occlusion1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Fluid/Blood Leak; Insufficient Device Problem Information
NURSE REPORTED THAT THE PATIENT WAS BEING INFUSED AT HOME AND THE CATHETER WAS LEAKING AT THE INSERTION SITE. THE CATHETER WAS REMOVED AND A SMALL FRACTURE WAS OBSERVED AT THE 3CM MARKING. PATIENT CONDIITON IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566743 ↗InjuryJun 19, 2026Fluid/Blood Leak; Insufficient Device Problem Information
NURSE REPORTED THAT PATIENT WITH CATHETER PLACED HAD ELBOW SWELLING. THERE WAS NO PAIN OR LEAKING AT THE SITE. ULTRASOUND DIAGNOSED DEEP VEIN THROMBOSIS.. IT IS UNKNOWN IF ANY INTERVENTION WAS REQUIRED. PATIENT CONDIITON IS ALSO UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 25566584 ↗InjuryJun 19, 2026Fluid/Blood Leak; Insufficient Device Problem Information
NURSE REPORTED THAT THERE WAS A LEAK AT THE INSERTION SITE LIKELY FROM A SUBCUTANEOUS VEIN THROMBOSIS (SVT) BUT STATES THIS WAS NOT OBSERVED AT THE HOSPITAL BUT REPORTED FROM A HOME HEALTH SERVICE. IT IS UNKNOWN IF ANY INTERVENTION WAS REQUIRED. PATIENT CONDITION IS ALSO UNKNOWN.
Patient problems: Thrombosis/Thrombus
MAUDE report 25566390 ↗InjuryJun 19, 2026Insufficient Device Problem Information
THE COMPLAINANT REPORTED A SUBCLAVIAN AND AXILLARY DEEP VEIN THROMBOSIS (DVT) IN A CANCER PATIENT. THE PATIENT WAS RECEIVING CHEMOTHERAPY THROUGH THE LINE. THE TYPE OF CHEMOTHERAPY USED IN TREATMENT WAS NOT IDENTIFIED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25566128 ↗MalfunctionJun 15, 2026Fluid/Blood Leak
COMPANY CONTACTED BY NURSE REPORTER REGARDING A HYDROMID CATHETER THAT ALLOWED FOR INFILTRATION OF MEDICATION TO UPPER RIGHT ARM. A LEAK OR RUPTURE OF THE CATHETER BODY. THE CATHETER WAS REMOVED AND REPLACED WITH NO CLINICAL IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25511099 ↗MalfunctionJan 6, 2026Fluid/Blood Leak
NURSE STATED THAT THE LINE WOULD NOT FLUSH. AFTER SOME EFFORT, THE LINE WAS ABLE TO BE FLUSHED BUT A LEAK WAS FOUND. PATIENT ASKED TO RETURN TO HEALTHCARE SITE. UPON ARRIVAL, THE DRESSING WAS SATURATED, AND WHEN REMOVED, THE CATHETER HAD SEPARATED FROM THE HUB OUTSIDE THE INSERTION SITE.
Patient problems: Obstruction/Occlusion
MAUDE report 23982223 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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