NIPRO SAFELET CATH CI+2025Recalls & reported problems
Nipro Medical Corporation · Intravascular catheter · Class 2
Data updated Oct 16, 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 10383790006368), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IV CATHETER WAS PLACED DURING A ROUTINE CANINE OVARIOHYSTERECTOMY THAT STARTED AT 8:47AM ON MONDAY (B)(6) 2025. THE IV CATHETER WOULD HAVE BEEN PLACED A FEW MINUTES BEFORE SURGERY. SURGERY ENDED AT 9AM, THE IV CATHETER WAS REMOVED AT APPROXIMATELY 9:05 AM AND IMMEDIATELY THE RECOVERY TECH NOTICED THE IV CATHETER WAS NOT INTACT. THE DOCTOR WENT BACK INTO SURGERY AT 9:10 AM TO TRY AND REMOVE IT. CATHETER HAD LESS THAN AN HOUR INSERTED IN THE VEIN. THE CATHETER WAS NOT SUCCESSFULLY REMOVED. ONLY THE HUB, THE POLYPROPYLENE SECTION MIGRATED. THIS IS THE FIRST TIME THIS TYPE OF INCIDENT OCCURRED. THE PATIENT IS STABLE; THE CARDIOLOGIST WAS UNSUCCESSFUL IN REMOVING THE CATHETER FROM A DISTAL PULMONARY ARTERY WHERE IT SETTLED. ADDITIONAL INFORMATION RECEIVED FROM THE CHIEF VETERINARY MEDICAL OFFICER STATING; THE PATIENT IS STABLE, AND THERE HAVE BEEN NO SECONDARY COMORBIDITIES LINKED TO THE ISSUE. THEY ARE WAITING FOR AN UPDATE REGARDING TIMING OF THE REMOVAL. AN ADVERSE EVENT REPORT WAS SUBMITTED TO HEALTH CANADA BY THE CHIEF VETERINARY MEDICAL OFFICER AND HE STATED THAT IT WAS INDICATED IN THE REPORT THAT THIS WAS LIKELY DUE TO USER ERROR AND THAT THERE WAS NO EVIDENCE TO SUGGEST DEVICE
Patient problems: Foreign Body In Patient
MAUDE report 22151178 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page