Medisystems Hemodialysis Fistula Needle Set with MasterGuard S9-7005MGRecalls & reported problems
Medisystems Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842289100978), received between Sep 1, 2017 and Sep 1, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2017Device Contamination with Chemical or Other Material
AFTER THE INSERTION OF NEEDLE INTO THE DIALYSIS GRAFT, IT WAS NOTED A RED SUBSTANCE AT THE DISTAL END (AWAY FROM THE PATIENT) OF TGHE MEDISYSTEM HEMODIALYSIS FISTULA NEEDLE SET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6839186 ↗
Other Needle, Fistula devices
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5002-33Jms Singapore Pte Ltd · Needle, Fistula6 deaths27 reports
- DORA BAIN-A.V.F-009SEBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula9 reports
- DORA BAIN-A.V.F-001SEBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula4 reports
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-7005-33Jms Singapore Pte Ltd · Needle, Fistula2 deaths4 reports
- NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER 15GX1" HTC-30W-D-CAPNipro Medical Corporation · Needle, fistula2 reports
- DORA BAIN-A.V.F-009SGBain Medical Equipment (Guangzhou) Co., Ltd. · Needle, Fistula1 report
- JMS WINGEATER A.V.FISTULA NEEDLE SET 820-5003-33Jms Singapore Pte Ltd · Needle, Fistula1 report
- JMS HARMONY A.V.FISTULA NEEDLE SET 827-1500-33Jms Singapore Pte Ltd · Needle, Fistula1 report
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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