NIPRO SAFETOUCH II SAFETY FISTULA NEEDLERecalls & reported problems across all models
Nipro Medical Corporation · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of NIPRO SAFETOUCH II SAFETY FISTULA NEEDLE by Nipro Medical Corporation in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between May 8, 2020 and May 11, 2026 — classified as 3 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NIPRO SAFETOUCH II SAFETY FISTULA NEEDLE problems
Device problems
- Retraction Problem25
- Fluid/Blood Leak4
- Break2
- Material Fragmentation2
- Material Puncture/Hole2
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Hemorrhage/Blood Loss/Bleeding4
- Needle Stick/Puncture2
- Pain2
- Bruise/Contusion1
- Post Operative Wound Infection1
- Skin Tears1
NIPRO SAFETOUCH II SAFETY FISTULA NEEDLE models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 17GX1-1/4" HC-30WCatheter,intravascular,therapeutic,short-term less than 30 days16 reports
- NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 15GX1" HC-30WCatheter,intravascular,therapeutic,short-term less than 30 days14 reports
- NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 16GX1-1/4" HTC-30WCatheter,intravascular,therapeutic,short-term less than 30 days2 reports
- NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE 16GX1-1/4" HC-30WCatheter,intravascular,therapeutic,short-term less than 30 days1 report
Recent NIPRO SAFETOUCH II SAFETY FISTULA NEEDLE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Fluid/Blood Leak; Material Puncture/Hole
CUSTOMER STATES THERE WAS A HOLE INSIDE OF THE TUBING OF A NEEDLE. DUE TO THE NEEDLE BEING EXPOSED TO BLOOD, IT IS UNAVAILABLE FOR REVIEW. SINCE REPORTING THIS COMPLAINT, THE CUSTOMER HAS CONFIRMED THAT THE HOLE WAS LOCATED DIRECTLY INSIDE OF THE TUBING, ADJACENT TO THE END CAP (NOT THE BEVEL SIDE). THE HOLE PENETRATED THE TUBING, CAUSING BLOOD TO ESCAPE THE TUBING AND DRIP OUT. APPROXIMATELY 200ML OF BLOOD LEAKED. REPLACEMENT FLUID WAS ADMINISTERED TO THE PATIENT WITH 15 MINUTES OF MONITORING THE DONOR. AFTER 15 MINUTES, DONOR LEFT THE FACILITY FEELING WELL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25143878 ↗InjuryMay 11, 2026Fluid/Blood Leak; Material Puncture/Hole
CUSTOMER STATES THERE WAS A HOLE INSIDE OF THE TUBING OF A NEEDLE. DUE TO THE NEEDLE BEING EXPOSED TO BLOOD, IT IS UNAVAILABLE FOR REVIEW. SINCE REPORTING THIS COMPLAINT, THE CUSTOMER HAS CONFIRMED THAT THE HOLE WAS LOCATED DIRECTLY INSIDE OF THE TUBING, ADJACENT TO THE END CAP (NOT THE BEVEL SIDE). THE HOLE PENETRATED THE TUBING, CAUSING BLOOD TO ESCAPE THE TUBING AND DRIP OUT. APPROXIMATELY 200ML OF BLOOD LEAKED. REPLACEMENT FLUID WAS ADMINISTERED TO THE PATIENT WITH 15 MINUTES OF MONITORING THE DONOR. AFTER 15 MINUTES, DONOR LEFT THE FACILITY FEELING WELL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25143164 ↗MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTING LEAKAGE OF BLOOD FROM THE CONNECTION POINT BETWEEN THE HARD PLASTIC AND THE TUBING. THERE WAS APPROXIMATELY 200ML OF BLOOD LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22145185 ↗MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTING LEAKAGE OF BLOOD FROM THE CONNECTION POINT BETWEEN THE HARD PLASTIC AND THE TUBING. THERE WAS APPROXIMATELY 200ML OF BLOOD LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22144968 ↗MalfunctionMar 1, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH RESULTING IN A NEEDLE STICK INJURY. STAFF SENT TO PHYSICIAN FOR EVALUATION, ROUTINE LAB WORK OFFERED BUT UNABLE TO CONFIRM IF THE STAFF HAD IT COMPLETED.
Patient problems: Needle Stick/Puncture
MAUDE report 16459713 ↗MalfunctionFeb 28, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH (SAFETY MECHANISM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456480 ↗MalfunctionFeb 28, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH (SAFETY MECHANISM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456065 ↗MalfunctionFeb 28, 2023Retraction Problem; Retraction Problem
NEEDLE DID NOT RETRACT INTO SHEATH RESULTING IN A NEEDLE STICK INJURY. STAFF SENT TO PHYSICIAN FOR EVALUATION, ROUTINE LAB WORK OFFERED BUT UNABLE TO CONFIRM IF THE STAFF HAD IT COMPLETED.
Patient problems: Needle Stick/Puncture
MAUDE report 16455786 ↗MalfunctionMay 27, 2021Material Fragmentation; Material Fragmentation
DURING DIALYSIS TREATMENT THE SMALL CLEAR PLASTIC RING BELOW THE SAFETY, HAD CRACKED AND FELL OFF. TREATMENT WAS COMPLETED AND THE NURSE WENT TO REMOVE THE AVF FISTULA NEEDLE AND NOTED IT WAS SITTING BY THE PATIENTS HAND. NO ISSUE REMOVING THE AVF NEEDLE. NO INJURIES OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11897958 ↗MalfunctionMay 27, 2021Material Fragmentation; Material Fragmentation
DURING DIALYSIS TREATMENT THE SMALL CLEAR PLASTIC RING BELOW THE SAFETY, HAD CRACKED AND FELL OFF. TREATMENT WAS COMPLETED AND THE NURSE WENT TO REMOVE THE AVF FISTULA NEEDLE AND NOTED IT WAS SITTING BY THE PATIENTS HAND. NO ISSUE REMOVING THE AVF NEEDLE. NO INJURIES OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11897875 ↗MalfunctionMay 27, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT). NO INJURIES ARE REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896853 ↗MalfunctionMay 27, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT). NO INJURIES ARE REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896604 ↗MalfunctionMay 10, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT), NO INJURIES ARE REPORTED AT THIS TIME. FACILITY HAS BEEN TRAINED AND HAS BEEN USING THE SAFETOUCH II NEEDLES FOR OVER 5 YEARS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803681 ↗MalfunctionMay 10, 2021Retraction Problem; Retraction Problem
NUMEROUS INSTANCES OF SAFETY DEVICE FAILING (FAILING TO CLIP, FAILING TO RETRACT), NO INJURIES ARE REPORTED AT THIS TIME. FACILITY HAS BEEN TRAINED AND HAS BEEN USING THE SAFETOUCH II NEEDLES FOR OVER 5 YEARS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803653 ↗MalfunctionMar 23, 2021Retraction Problem; Retraction Problem
SEVERAL NEEDLES WOULD NOT RETRACT DURING THEIR DONATION PROCESS, NO INJURIES ARE REPORTED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11559017 ↗
Other Nipro Medical Corporation products
All Nipro Medical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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