BioFlo 45872Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965458720), received between Aug 17, 2021 and Dec 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED THAT AN END-USER EXPERIENCED AN ISSUE WITH A BIO-STABLE 5F DL-55 CM IR-145 KIT NON-VALVED PICC. 48 HOURS POST PLACEMENT, A LEAK WAS OBSERVED AT THE INSERTION SITE WHEN INFUSING MEDICATION AND FLUIDS. THE PATIENT'S LEFT CUBITAL FOSSA WHERE PICC WAS LOCATED WAS OBSERVED TO SWOLLEN. THE CATHETER WAS REMOVED AND REPLACED DUE TO REDUCED FLOW RATE AT BOTH LUMENS AND WORSENING SWELLING.

  Patient problems: Swelling/ Edema

  MAUDE report 20901555 ↗
• MalfunctionApr 19, 2023Stretched; Infusion or Flow Problem; Stretched; Infusion or Flow Problem

  DURING THE INSERTION PROCEDURE OF A PICC FROM A BIO-STABLE 5F DL-55CM IR-145 KIT NON-VALVED KIT, UNDER FLUOROSCOPIC AND GUIDE-WIRE ASSISTANCE, THE PROVIDER WAS UNABLE TO RETRIEVE THE CATHETER THAT WAS THREADED OVER THE WIRE. AFTER MULTIPLE MANIPULATIONS, THE GUIDEWIRE WAS ABLE TO BE RETRIEVED, LEAVING THE CATHETER SUCCESSFULLY INSITU. THE NEXT DAY, THE PATIENT PRESENTED WITH A COMPLAINT OF SWELLING AT THE PICC INSERTION SITE AT THE LEFT CUBITAL FOSSA. THE CATHETER WAS THEN REMOVED DUE TO REDUCE FLOW RATE IN BOTH LUMENS AND THE WORSENING SWELLING. IT WAS SUSPECTED CATHETER WAS OVERSTRETCHED OR LEAKING. UPON INSPECTION OF THE REMOVED CATHETER, IT WAS NOTED THE MID-PORTION OF THE CATHETER WAS STRETCHED OUT AND DEFECTIVE.

  Patient problems: Swelling/ Edema

  MAUDE report 16771837 ↗
• MalfunctionAug 17, 2021Difficult to Remove; Difficult to Remove

  A DISTRIBUTOR REPORTED AN ISSUE THEIR CUSTOMER EXPERIENCED WHEN USING A BIO-STABLE 5F DL-55CM IR-145 KIT NON-VALVED PROCEDURE KIT. IT WAS REPORTED THAT THE PROVIDER WAS PERFORMING THE BIOFLO PICC INSERTION FOR A PEDIATRIC CASE UNDER SEDATION. ACCORDING TO THE END USER, "PEDIATRIC CASES CAN BE CHALLENGING DUE TO SMALL VEINS, BUT IT WAS SMOOTH PUNCTURE FOR THIS CASE INTO THE VEIN. BUT UNEXPECTEDLY, THE CHILD HAD A STENOSIS PROXIMAL TO THE PUNCTURE SITE, WHICH WAS NOT KNOWN ABOUT BEFORE HAND, AND IT DAMAGED THE GUIDE WIRE TIP." AFTER THE TIP OF GUIDE WIRE WAS DAMAGED, THE END USER WAS UNABLE PULL OUT THE WIRE FROM PUNCTURE NEEDLE AS IT STUCK AT NEEDLE TIP. THE PROVIDER HAD TO ABANDON THE ACCESS DUE TO THIS REASON. THE PROVIDER ENDED UP NEEDING TO RE-PUNCTURE ANOTHER VEIN, AND INSERTED THE CATHETER WITH THE AID OF ANOTHER GUIDE WIRE (MICRO-PUNCTURE SET GUIDE WIRE) AS THE TIP OF THE INITIAL WIRE WAS STUCK IN THE 1ST PUNCTURE NEEDLE TIP AND DAMAGED (NON-SALVAGEABLE). THE PHYSICIAN REPORTED TO THE DISTRIBUTOR A CONCERN ABOUT THE PATIENT BEING UNDER EXTENDED CONSCIOUS SEDATION FOR AN ADDITIONAL 45 MINUTES WHILE THE ISSUE WAS RESOLVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330925 ↗