BioFlo 45885Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965458850), received between Apr 5, 2021 and Aug 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL-55CM IR-145 KIT NON-VALVED WITH NITINOL GW. APPROXIMATELY A MONTH AND 1/2 AFTER PLACEMENT, A LEAK WAS NOTED. ON EXAMINATION, A SMALL PINHOLE WAS FOUND; THEREFORE, THE PICC WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173497 ↗
• MalfunctionApr 9, 2021Migration; Migration

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL-55CM. IT WAS REPORTED THE PICC DISLOCATED [CATHETER MALPOSITION] IN THE JUGULAR VEIN, DURING INJECTION OF CONTRACT MEDIUM. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT BUT THE DEVICE WAS REMOVED. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640821 ↗
• MalfunctionApr 5, 2021Migration; Migration

  EVENT 2 OF 2 (SAME PATIENT) REFERENCE (B)(4), 1317056-2021-00069 FOR FIRST EVENT. THE DISTRIBUTOR REPORTED THE SAME PATIENT HAD AN ISSUE WITH THE SECOND BIO-STABLE 4F SL-55CM PLACED. IT WAS REPORTED THE SAME ISSUE OCCURRED; DURING INJECTION OF CONTRACT MEDIUM (4ML/SEC) FOR A CT SCAN, THE PICC DISLODGED/MISPLACED FROM THE VENA CAVA INTO THE SUBCLAVIAN VEIN. ULTIMATELY, THE PICC WAS REMOVED AND REPLACED. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612796 ↗