BioFlo 75-063Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI H965750630), received between Sep 20, 2021 and Dec 19, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Material Puncture/Hole; Material Puncture/Hole

  AN END USER EXPERIENCED AN ISSUE WITH A CATHETER FROM BIOFLO PICC (V) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W NIT AND DF DRAPE. IT WAS REPORTED THAT A HOLE DEVELOPED IN THE CATHETER, APPROXIMATELY 2 CM FROM THE INSERTION SITE. THE LEAK WAS NOTED 11 DAYS POST-INSERTION. THE PICC WAS REMOVED AFTER LEG SWELLING/EDEMA AND LEAKAGE OF FLUID WAS OBSERVED. THE PICC WAS REPLACED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: Swelling/ Edema

  MAUDE report 23850064 ↗
• InjuryDec 19, 2025Material Puncture/Hole; Material Puncture/Hole

  AN END USER EXPERIENCED AN ISSUE WITH A CATHETER FROM BIOFLO PICC (V) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W NIT AND DF DRAPE. IT WAS REPORTED THAT A HOLE DEVELOPED IN THE CATHETER, APPROXIMATELY 5-6 CM FROM THE HUB. THE LEAK WAS NOTED 6 DAYS POST-INSERTION. THE PICC WAS REMOVED AFTER THE SITE BECAME EDEMATOUS AND WAS LEAKING TPN (TOTAL PARENTERAL NUTRITION).

  Patient problems: Peripheral Edema

  MAUDE report 23850063 ↗
• MalfunctionApr 3, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED FROM A TECH THAT THEY HAD A PICC FROM A TANDEM BIOFLO PICC (V) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W NIT AND DF DRAPE KIT THAT WAS LEAKING FROM CRACK IN PURPLE LUMEN. THE VAT WAS NOTIFIED ON 03/08/2023 THAT ONE OF THE LUMENS WAS LEAKING. ON ASSESSMENT, THE PURPLE LUMEN WAS CRACKED JUST BELOW WHERE THE NEEDLESS CONNECTOR CONNECTS TO THE LUMEN. IT WAS DIFFICULT TO SEE, VISUALLY, UNLESS NEEDLESS CONNECTOR IS SCREWED IN JUST RIGHT, BUT WHEN SALINE IS HOOKED UP, IT SPRAYS OUT OF THE LUMEN, SHOWING INDEED THERE IS A CRACK. THE LAST TIME VAT ASSESSED THE LINE WAS ON 03/06/2023 AND THERE WERE NO ISSUES AT THAT TIME. SINCE 03/06/2023 THE PATIENT WAS ONLY ON 2 IV MEDS THAT WERE COMPATIBLE, SO THEY COULD HAVE BEEN JUST USING ONE LUMEN. WHEN ASKED TO ASSESS ON 03/08/2023, HER INFUSIONS WERE CONNECTED TO THE GREY LUMEN. AND IT WAS THE PATIENT WHO NOTED SHE FELT WET WHEN THE BEDSIDE RN ASSESSED THE DEVICE. THE RN DIDN'T NOTICE UNTIL PATIENT ASKED WHERE THE WETNESS WAS COMING FROM.THE PATIENT HAS BEEN INTERMITTENTLY CONFUSED AND LETHARGIC. THE REPORTING TECH WAS UNSURE EXACTLY WHEN THE CRACK HAPPENED (JUST THAT IT HAD TO BE BETWEEN 03/06/2023 AND 03/08/2023), AND WHAT/IF BEDSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662510 ↗
• MalfunctionApr 18, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED AN ISSUE WITH A BIOFLO PICC (V) 5FDL-55CM MAXIMAL BARRIER NURSING KIT. THE PICC LINE WAS PLACED IN THE PATIENT'S LEFT, MID-THIGH, FEMORAL ARTERY, DUE TO SVC COMPRESSION. DURING INITIAL PLACEMENT, ADEQUATE BLOOD RETURN WAS ACHIEVED; HOWEVER, APPROXIMATELY 3 HOURS AFTER PLACEMENT, THE PICC LINE WAS NOTED TO BE DIFFICULT TO FLUSH AND WOULD NOT GIVE BLOOD RETURN. BOTH THE PURPLE AND GREY LUMENS WERE AFFECTED. A KUB WAS PERFORMED AND CONFIRMED THAT THE TIP HAD NOT MIGRATED SO ALTEPASE WAS ORDERED FOR INSTILLING IN BOTH LUMENS. AFTER ALTEPASE, BOTH LINES HAD POSITIVE BLOOD RETURN; HOWEVER, THE GRAY LUMEN WAS STILL SLUGGISH, PROMPTING A SECOND DOSE OF ALTEPASE. BLOOD RETURN COULD NOT BE ESTABLISHED AFTER THE SECOND DOSE; THEREFORE, IT WAS ASSUMED THAT THERE WAS AN ISSUE WITH THE DEVICE, OTHER THAN, OR IN ADDITION TO, POSSIBLE CLOTTING. DIFFICULTY FLUSHING THE PORT AND ESTABLISHING BLOOD RETURN CONTINUED TO BE AN ISSUE. BLOOD RETURN COULD BE ESTABLISHED WITH PATIENT LYING IN RIGHT, RECUMBENT POSITION ; HOWEVER, IT WAS NOT POSSIBLE IF PATIENT WAS IN A LOW FOWLER'S POSITION. THE RN BELIEVED THAT THE LINE MAY BE FLIPPING OR TWISTING IN ON ITSELF, WHEN THE PATIENT STRAIGHTENS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135565 ↗
• MalfunctionSep 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A VASCULAR ACCESS (VA) NURSE REPORTED AN ISSUE WITH A BIOFLO PICC (V) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W NIT AND DF DRAPE PG. THE NURSE RECEIVED A CONSULT REQUEST TO EVALUATE THE PICC THAT WAS PLACED A FEW DAYS PRIOR. UPON ENTERING THE PATIENT'S ROOM, IT WAS NOTED THAT THE HUB WAS MISSING FROM THE CLEAR EXTENSION TUBING. THE NURSE FELT IT LOOKED LIKE IT WAS CUT OFF. THE CLEAR EXTENSION TUBING WAS COVERED BY A TRANSPORT MEDICAL TAPE. THE ANGIODYNAMICS CLINICAL SPECIALIST, WHO WAS PRESENT, ADVISED THE VA NURSE TO USE A KELLY CLAMP TO CLAMP THE TUBING TO PREVENT AIR EMBOLI AND/OR BLEEDING. THE PATIENT'S NURSE REPORTED FINDING THE LUMEN DETACHED AND WAS ABLE TO SHOW THE RESPONDING NURSE AND CS THE COMPONENT IN THE TRASH CAN, STILL CONNECTED TO THE IV TUBING AND IV FLUID BAG. IT WAS ALSO REPORTED THAT THE PATIENT'S SITTER STATED THAT THE PATIENT FREQUENTLY "TWISTS AND TURNS" IN BED. THE VA NURSE RECEIVED ORDERS TO EXCHANGE THE BIOFLO PICC 5FR DL PASV WITH A BIOFLO MIDLINE 4FR SL. THE REPLACEMENT PROCEDURE WAS COMPLETED WITH OUT ANY INCIDENT. BOTH THE DETACHED PICC HUB AND BIOFLO PICC 5FR DL PASV WERE SAVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496171 ↗