ARROW IPN924167Recalls & reported problems
Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) Three-Lumen PICC pre-loaded with Arrow(R) NaviCurve(TM) Stylet · Class 2 · Implant
All models of ARROW (1494)
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 10801902208719), received between Apr 23, 2025 and Jun 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Material Separation; Material Separation
IT WAS REPORTED "PATIENT PULLED OFF BLUE LUMEN". A NEW PICC WAS INSERTED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION. THE PATIENT'S CURRENT CONDITION "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203710 ↗MalfunctionApr 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED "DURING A DIFFICULT PICC INSERTIONS, THE PICC WAS OBSERVED TO HAVE COILED ON THE TIPTRACKER. WHEN INSERTER PULLED BACK THE PICC BEFORE READVANCING, IT IS BELIEVED THAT THE PICC PULLED BACK OVER THE STYLET, LEAVING THE STYLET EXTENDING BEYOND THE CATHETER TIP. WHEN THE PICC WAS READVANCED INTO THE PATIENT, THE ECG SHOWED VENTRICULAR PLACEMENT. TROUBLE SHOOTING WAS PERFORMED, DURING WHICH IT WAS REALIZED THAT THE STYLET HAD LIKELY EXTENDED BEYOND THE TIP OF THE CATHETER. THE PICC AND STYLET WERE REMOVED ENTIRELY FROM THE PATIENT, THE STYLET WAS REPOSITIONED WITHIN THE CATHETER AND THE CATHETER WAS REINSERTED INTO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890247 ↗
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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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