NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 16GX1-1/4" HC-30WRecalls & reported problems
Nipro Medical Corporation · 16Gx1-1/4" Fixed Hub 11" Tubing · Class 2
All models of NIPRO SAFETOUCH II SAFETY FISTULA NEEDLE (4)
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 00383790000147), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Retraction Problem” (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
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2020Retraction Problem; Retraction Problem
SAFETOUCH II NEEDLE WOULD NOT RETRACT INTO THE SAFETY UPON REMOVAL. THIS WAS NOTICED UPON REMOVING THE NEEDLE POST TREATMENT. NO BLOOD WAS LOST, NO ADVERSE EVENTS OCCURRED, NO NEEDLE STICK RESULTED. THIS FACILITY HAS USED SAFETOUCH II SINCE (B)(6) 2019. THE CLINICAL SPECIALIST PROVIDED TRAINING ON WEDNESDAY, (B)(6) 2019, WEDNESDAY, (B)(6) 2019, AND WEDNESDAY, (B)(6) 2020 TO PROVIDE SUPPLEMENTAL TRAINING AND SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11036290 ↗
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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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