BioFlo 60M140606Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI H96560M1406060), received between Sep 1, 2016 and Feb 12, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Crack” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Crack; Crack

  A USER FACILITY REPORTED THAT A PATIENT'S BIOFLO PICC W/PASV CRACKED AT THE HUB OF THE DEVICE. THE PATIENT'S BIOFLO PICC WAS REMOVED AND REPLACED. THE COMPLAINT DEVICE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369762 ↗
• MalfunctionJan 6, 2025Crack; Crack

  A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A TANDEM 5F DL BIOFLO PASV PICC, NEW YORK UNIVERSITY MEDICAL CENTER. IT WAS REPORTED POST PLACEMENT, THAT THE PICC'S HUB WAS CRACKED. THE PICC REQUIRED REMOVAL AND REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079926 ↗
• MalfunctionJan 6, 2025Crack; Crack

  A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A TANDEM 5F DL BIOFLO PASV PICC, NEW YORK UNIVERSITY MEDICAL CENTER. IT WAS REPORTED POST PLACEMENT, THAT THE PICC'S PURPLE HUB WAS CRACKED. THE PICC REQUIRED REMOVAL AND REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079924 ↗
• MalfunctionDec 27, 2024Crack; Crack

  A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A TANDEM 5F DL BIOFLO PASV PICC, NEW YORK UNIVERSITY MEDICAL CENTER. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB WAS CRACKED, REQUIRING REMOVAL AND REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027166 ↗
• MalfunctionDec 27, 2024Crack; Crack

  A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A TANDEM 5F DL BIOFLO PASV PICC, (B)(6). IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB WAS CRACKED, REQUIRING REMOVAL AND REPLACEMENT. PER STAFF, THEY HAVE NOT USED CLAMPS OR EXCESS TORQUE ON THE CONNECTION TO THE NEEDLELESS ACCESS VALVES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026643 ↗
• MalfunctionDec 27, 2024Crack; Crack

  A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A TANDEM 5F DL BIOFLO PASV PICC, (B)(6). IT WAS REPORTED POST PLACEMENT, THAT THE PICC'S PROXIMAL HUB WAS CRACKED, REQUIRING REMOVAL AND REPLACEMENT. PER STAFF, THEY HAVE NOT USED CLAMPS OR EXCESS TORQUE ON THE CONNECTION TO THE NEEDLELESS ACCESS VALVES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026640 ↗
• MalfunctionDec 27, 2024Crack; Crack

  A SPECTRUM SENIOR DISTRICT MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A TANDEM 5F DL BIOFLO PASV PICC, (B)(6) CENTER. IT WAS REPORTED POST PLACEMENT, THAT THE PICC'S PURPLE HUB WAS CRACKED, REQUIRING REMOVAL AND REPLACEMENT. PER STAFF, THEY HAVE NOT USED CLAMPS OR EXCESS TORQUE ON THE CONNECTION TO THE NEEDLELESS ACCESS VALVES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026635 ↗
• MalfunctionSep 26, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED: THERE HAS BEEN A PICC MALFUNCTION ON A LINE WE PLACED 2 WEEKS AGO. THERE APPEARS TO BE A HOLE IN THE LINE THAT IS LEAKING FLUID BEING ADMINISTERED TO THE PATIENT. THERE WAS NO INDICATION THE PATIENT WAS ADVERSELY AFFECTED BY THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9124789 ↗
• MalfunctionSep 1, 2016Fracture; Fracture

  AS REPORTED, AN INDWELLING VALVED PICC WAS REMOVED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5920867 ↗
• MalfunctionSep 1, 2016Fracture; Fracture

  AS REPORTED, AN INDWELLING VALVED PICC WAS REMOVED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5920859 ↗
• MalfunctionSep 1, 2016Fracture; Fracture

  AS REPORTED, AN INDWELLING VALVED PICC WAS REMOVED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5920857 ↗