ARROW IPN928995Recalls & reported problems
Teleflex Incorporated · Arrowg+ard Blue(R) One-Lumen CVC
All models of ARROW (1494)
Data updated Oct 18, 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 10801902218367), received between May 19, 2026 and Aug 4, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Split, Cut or Torn1
- Off-Label Use1
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.
MalfunctionAug 4, 2026Fluid/Blood Leak; Off-Label Use
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136229 ↗MalfunctionMay 19, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT ON (B)(6) 2026, "DURING HOSPITAL ROUNDS, A TEAR WAS IDENTIFIED ON THE EXTENSION LINE OF A CENTRAL VENOUS CATHETER (CVC), RESULTING IN FAILURE OF FLUID INFUSION. THE CATHETER WAS IMMEDIATELY CLAMPED, AND THE PHYSICIAN WAS NOTIFIED. FOLLOWING DISINFECTION, THE CATHETER WAS REMOVED, AND COMPRESSION HEMOSTASIS WAS APPLIED AT THE PUNCTURE SITE. THE DEVICE WAS REPLACED WITH A NEW CATHETER." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL AND REPLACEMENT OF THE AFFECTED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222171 ↗
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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