ARROW CS-15232-VFERecalls & reported problems
Teleflex Incorporated · Class 2 · Implant
All models of ARROW (1494)
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 10801902154177), received between May 25, 2026 and May 25, 2026 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
MalfunctionMay 25, 2026Fluid/Blood Leak
IT WAS REPORTED THAT "AFTER INSERTING THE CATHETER, THE PHYSICIAN NOTICED THAT AIR WAS BEING DRAWN INTO THE CONNECTOR DURING ASPIRATION. THE LEAK COULD NOT BE PINPOINTED. THE PROBLEM WAS RESOLVED BY OPENING ANOTHER SET AND USING THE CONNECTOR CONTAINED THEREIN." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25272054 ↗
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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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