BioFlo 45871Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H965458710), received between Jul 7, 2017 and Apr 21, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Crack

  AN END USER REPORTED AN ISSUE WHEN USING THE BIOFLO 5F DL-55CM, MST-70 KIT, NON-VALVED PG. THE GRAY HUB WAS OBSERVED TO BE CRACKED ALONG THE LUER THREADS. THE AFFECTED DEVICE HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948539 ↗
• MalfunctionDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM MST-70 KIT NON-VALVED. ORIGINALLY WHEN THE PATIENT REPORTED THE BROKEN CLAMP, THE CLAMP WAS REMOVED AND A TEMPORARY CLAMP WAS APPLIED. THEN FEW DAYS LATER PATIENT CALLED AND REPORTED THAT LINE WAS PULLED BACK BY 5 CM THE TEMPORARY CLAMP CAUGHT HER SWEATER AND THE LINE CAME OUT. AN OVERWIRE WAS DONE AND THE LINE WAS EXCHANGED FOR A SINGLE LUMEN PICC ON (B)(6) 2024. THIS PATIENT HAS HAD MULTIPLE PICCS OVER THE YEARS AND DOES NEED LONG TERM ACCESS FOR TPN. SHE ALWAYS HAS BEEN VERY GOOD WITH HER LINES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026633 ↗
• MalfunctionMay 7, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING APICC FROM A BIOFLO PICCS - NON-VALVED, MST 70CM DL 5F SS KIT. THE NURSE FOUND THE PURPLE HUB IS BROKEN WHEN SHE FLUSHING THE CATHETER. THE PICC WAS REMOVED AND REPLACED WITH A NEW OF THE SAME. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259747 ↗
• InjuryJul 7, 2017Crack; Crack

  AS REPORTED BY HOSPITAL IN (B)(6), A PICC WAS INSERTED ON (B)(6) 2017 - INSERTED IN THE RIGHT BASILIC WITH THE TIP IN THE SVC (41 CM INSERTED). THROUGHOUT THE NIGHT ON (B)(6) THE PATIENT DEVELOPED A SWOLLEN ARM AND LEAKAGE FROM THE INSERTION SITE. ULTRASOUND AND CXR WER COMPLETED ON (B)(6) - THE TIP PLACEMENT WAS CONFIRMED AND NO CLOT WAS NOTED ALONG THE ACTUAL PICC. WITH DRESSING CHANGE AND NS FLUSHING, DEFINITE LEAKAGE WAS NOTED FROM THE SITE. INFUSIONS HAD BEEN HELD SINCE THE SWELLING WAS NOTED. AT THE SURGICAL TEAMS DECISION, THE PICC WAS REMOVED. IT WAS FOUND TO HAVE A SPLIT IN THE CATHETER AT THE 3 CM MARK. IT HAS BEEN INDICATED THAT THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Swelling

  MAUDE report 6692329 ↗