BioFlo 45870Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H965458700), received between Mar 13, 2020 and May 13, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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, 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2020Crack; Crack

  IT WAS REPORTED THAT A BIOFLO NON-VALVED PICC LINE EXPERIENCED A HUB CRACK WHEN CHANGING OUT THE RYMED END CAPS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED BUT PATIENT REQUIRED PICC REPLACEMENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052316 ↗
• MalfunctionMay 13, 2020Crack; Crack

  IT WAS REPORTED THAT A BIOFLO NON-VALVED PICC LINE EXPERIENCED A HUB CRACK WHEN CHANGING OUT THE RYMED END CAPS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED BUT PATIENT REQUIRED PICC REPLACEMENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052315 ↗
• MalfunctionMay 13, 2020Crack; Crack

  IT WAS REPORTED THAT A BIOFLO NON-VALVED PICC LINE EXPERIENCED A HUB CRACK WHEN CHANGING OUT THE RYMED END CAPS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED BUT PATIENT REQUIRED PICC REPLACEMENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052311 ↗
• MalfunctionMay 13, 2020Crack; Crack

  IT WAS REPORTED THAT A BIOFLO NON-VALVED PICC LINE EXPERIENCED A HUB CRACK WHEN CHANGING OUT THE RYMED END CAPS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED BUT PATIENT REQUIRED PICC REPLACEMENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052310 ↗
• MalfunctionMay 13, 2020Crack; Crack

  IT WAS REPORTED THAT A BIOFLO NON-VALVED PICC LINE EXPERIENCED A HUB CRACK WHEN CHANGING OUT THE RYMED END CAPS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED BUT PATIENT REQUIRED PICC REPLACEMENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052309 ↗
• MalfunctionMar 13, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED: BIOSTABLE PICC LINE CRACKED. DEVICE WAS REMOVED AND REPLACED. NO PATIENT HARM OR INJURY DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829112 ↗