HEMO-FLOW® XF MC641522Recalls & reported problems
Medical Components, Inc. · 15.5F X 28CM PRE-CURVED HEMO-FLOW® XF CATHETER FULL SET (CUFF 23CM FROM TIP) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908084016), received between Sep 23, 2020 and Jan 24, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Disconnection1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient1
- Respiratory Insufficiency1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2023Disconnection; Disconnection
PATIENT HAD UNEVENTFUL INITIATION OF TREATMENT AT OUTPATIENT DIALYSIS SETTING. CVC BLOOD LINES REVERSED TO ACHIEVE CLINICAL PARAMETERS AT ONSET OF TREATMENT. ONE HOUR INTO TREATMENT RN RESPONDED TO ALARM FOR PATIENT ON MACHINE, PT SYMPTOMATIC WITH CVC SEPARATION. STAFF RECONNECTED LINE AND NOTICED AIR IN ARTERIAL LIMB OF LUMEN. STAFF WITHDREW AIR WITH STERILE SYRINGE, AND SEND TO ED. PATIENT DISCHARGED HOME WITH ORIGINAL CATHETER WITHOUT INTERVENTION AFTER HEAD CT. NURSE PRACTITIONER ORDERED PATIENT FOR NEW CVC PLACEMENT. CVC IN USE AT TIME OF EVENT WAS PLACED ON (B)(6) 2019 WITHOUT ANY REPAIRS OR PRIOR MALFUNCTION.
Patient problems: Respiratory Insufficiency
MAUDE report 16233829 ↗MalfunctionSep 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED FROM MAUDE REPORT MW5096104: PATIENT WAS RECEIVING DIALYSIS AT BEDSIDE. DIALYSIS NURSE NOTICED BLEEDING FROM THE BLUE PORT. WHEN SEEN THE PLASTIC PART NEAR THE BLUE PORT WAS OPEN. CATHETER WAS THEN REMOVED. THE TIP OF THE CATHETER WAS SENT FOR CULTURE. DRESSING APPLIED TO RIGHT CHEST, NO FURTHER BLEEDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10573072 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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