BioFlo 45889Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI H965458890), received between May 6, 2016 and Aug 4, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A SPECTRUM TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 5F DL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. ON (B)(6) 2025, THE NURSE ON DUTY NOTED THAT THE PATIENT PICC LINE WAS LEAKING ON THE TUBING. IMMEDIATELY THE NURSE STOPPED THE TPN WHICH WAS RUNNING AND NOTIFIED THE ON CALL HOUSE OFFICER. ON CALL HOUSE OFFICER REVIEWED AND ADVISED TO STOP USING PICC LINE. TEAM AND CARDIOVASCULAR NURSE REVIEWED ON (B)(6) 2025 AND FLUSHED WITH SALINE AND CONFIRMED THE PICC WAS LEAKING OUTSIDE THE PATIENT. IT WAS ADVISED TO REMOVE THE PICC LINE AND IT WAS REMOVED ON (B)(6) 2025 BY THE NURSE. THE PICC WAS REPLACED THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700995 ↗
• MalfunctionJun 9, 2025Crack; Crack

  A DISTRIBUTOR REPORTED THAT AN END USER EXPERIENCED BIOFLO 5F DOUBLE LUMEN HUB CRACKS REQUIRING REMOVAL OF THE DEVICE FROM THE PATIENT. THE PATIENT'S BIOFLO PICC HAD INITIALLY BEEN PLACED IN THE RIGHT VENA CEPHALIC TO BEEN USED FOR NUTRITION. ELEVEN DAYS POST PLACEMENT, A CRACK WAS DISCOVERED IN THE DISTAL END OF THE CLAVICLE/HUB. THERE WAS STILL REPORTED TO BE GOOD INFLOW AND OUTFLOW IN BOTH RUNS AND WAS NOT DISCONNECTED AT THIS TIME. THE END USER PLACED TAPE OVER THE DEVICE AND USED A STERILE PLUG ON THE END OF THE HUB. THREE WEEKS LATER A CRACK/LEAK WAS ALSO DISCOVERED ON THE OTHER CLAVICLE/HUB. AT THIS TIME THE PATIENT'S PICC WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166715 ↗
• MalfunctionJun 9, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 5F DL 55CM MST-70 KIT VALVED, WITH NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT THERE WAS A FRACTURE OF ONE LUMEN NEAR THE FITTING OF THE POWER PICC. IT OCCURRED ON THE SURGICAL WARD, (B)(6) 2025 AND WAS NOTED DURING A DRESSING CHANGE. THE PICC HAD BEEN INSERTED VIA II CNC CANNULATION, NOT BY ICU, AND FOR THE PURPOSE OF TPN. THE PICC WAS REMOVED AND IT IS UNKNOWN IF IT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166700 ↗
• MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO 5F DL-55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. THE PATIENT UNDERWENT AN ATTEMPT TO PUNCTURE A PICC CATHETER IN THE RIGHT UPPER LIMB. AFTER RIGHT BASILIC VEIN, GUIDED BY USG, THERE WAS NO ADEQUATE PROGRESSION OF THE GUIDEWIRE. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE WITH DIFFICULTY, AND AFTER SUCH AN ATTEMPT, IT WAS NOT POSSIBLE TO REMOVE IT WITH RUPTURE OF IT WITH THE DISTAL END RETAINED IN THE SUBCUTANEOUS TISSUE OF THE PATIENT. IT WAS REPORTED THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20224637 ↗
• MalfunctionNov 8, 2023Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 5F DL 55CM MST-70 KIT, VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THAT "THE HUB ON THE PURPLE LUMEN HAS CRACKED. THE CRACK WAS FOUND TO HAVE OCCURRED AT THE AREA OF THE RIDGES, WHERE THE NEEDLELESS ACCESS DEVICE SCREWS ON." IT WAS NOTED THAT THIS WAS DISCOVERED BY NURSE(S) WHEN DRAWING BACK AIR WITH A SYRINGE DURING ASPIRATION OF THE LUMEN. THE PICC WAS THEN REMOVED ON (B)(6) 2023, AND DID NOT REQUIRE A REPLACEMENT. THERE WAS NO REPORTED INJURY/HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092677 ↗
• MalfunctionJan 24, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PICC FROM A BIO-STABLE 5F DL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE KIT. THE PATIENT'S PICC'S INSERTION HAD BEEN DONE WITH LOCAL ANESTHETIC AND WAS GUIDED/CONFIRMED BY ULTRASOUND WITHOUT COMPLICATION. FINAL TIP POSITION WAS CONFIRMED TO BE SUPERIOR VENA CAVA (SVC). THE PATIENT HAD RECEIVED 2 DAYS OF CHEMO THROUGH THE PICC ON MONDAY (19TH DECEMBER) AND TUESDAY (20TH DECEMBER) WITHOUT ANY ISSUES. AFTER THE A.M. DOSE OF CHEMO ON 21ST DECEMBER (WEDNESDAY), IT WAS IDENTIFIED THAT THE ENTRY POINT OF THE PICC WAS LEAKING. THERE WAS AN ACCUMULATION OF FLUID UNDER THE DRESSING (APPROX. 5 MILLILITRES POOLED). IT WAS REDRESSED AND FLUSHED WELL WITH FLUID LEAKING ONLY ON FLUSHING THE GREY LUMEN. THEY CONTINUED TO USE THE PURPLE LUMEN OF THE PICC FOR NON-CYTO FLUIDS FOR SEVERAL HOURS. IT THEN BEGAN LEAKING AGAIN, FLUID WAS LEAKING AROUND THE INSERTION POINT WHERE THE PICC MET THE SKIN. INITIALLY THIS WAS ONLY A SMALL VOLUMES AND THE MAJORITY OF THE INFUSION WAS GOING IN. (IT WAS THOUGHT TO BE A PARTIAL OCCLUSION). AFTER ABOUT AN HOUR, THE PICC WAS LEAKING NEARLY ALL OF THE INFUSION FLUID OUT AROUND THE PICC THEREFORE, I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232502 ↗
• MalfunctionJul 21, 2021Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH THE NITINOL GUIDEWIRE IN A BIO-STABLE 5F DL 55CM MST-70 KIT. THE PATIENT WAS CANNULATED AND THE WIRE WAS INSERTED, BOTH WITH NO DIFFICULTY. WHEN THE PROVIDER WENT TO PULL OFF THE NEEDLE, THE GUIDEWIRE WAS STUCK AT THE NEEDLE HUB, SO, SHE THEN TRIED TO REMOVE THE INTRODUCER SHEATH AND GUIDEWIRE TOGETHER WITH NO SUCCESS, WHICH WOULD RESULT IN LOSING VEIN ACCESS. A DOCTOR WAS CALLED TO ASSIST AND IT WAS DETERMINED TO PERFORM A CUT DOWN TO REMOVE THE GUIDEWIRE. THE PHYSICIAN HAD TO MAKE AN INCISION THAT WAS A COUPLE OF CENTIMETERS TO RETRIEVE GUIDEWIRE. ONCE REMOVED, THE GUIDEWIRE WAS OBSERVED TO HAVE A KNOT AT DISTAL TIP AND COULD NOT BE RETRACTED OUT OF INTRODUCER. THE INCISION DID NOT REQUIRE SUTURES TO CLOSE. IT WAS DETERMINED TO PLACE THE PICC IN THE PATIENT'S OTHER ARM, IN WHICH A BARD GUIDEWIRE WAS USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204985 ↗
• MalfunctionDec 1, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  ADDITIONAL INFORMATION PROVIDED REPORTED THE DEFECTIVE PICC WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927478 ↗
• MalfunctionApr 2, 2018Fracture; Fracture

  AS REPORTED, A BIOFLO PICC WHICH HAD BEEN INSERTED ON (B)(6) 2017 WAS REMOVED ON (B)(6) 2018 DUE TO FLUID LEAKING WHEN THE CATHETER WAS FLUSHED. UPON REMOVAL, A HOLE AT THE JUNCTION OF THE PICC AND THE SUTURE WING WAS NOTED. IT HAS BEEN INDICATED THAT THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7388017 ↗
• InjurySep 26, 2017Product Quality Problem; Unstable; Product Quality Problem; Unstable

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), "THE PEEL-APART SHEATH AND DILATOR (PACKAGED WITH THE BIOFLO PICC) WILL NOT LOCK TOGETHER RESULTING IN SEPARATION ON INSERTION TO THE VESSEL AND...ON ONE OCCASION A HAEMATOMA."

  Patient problems: Hematoma

  MAUDE report 6893321 ↗
• MalfunctionMay 17, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4), "DOUBLE LUMEN PICC LEAKING WHEN USED FOR INFUSION. NEEDED REPLACEMENT." THE USED DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5659465 ↗
• MalfunctionMay 17, 2016Fracture; Fracture

  AS REPORTED BY (B)(6) DISTRIBUTOR IN THE (B)(6), A PATIENT HAD A SINGLE LUMEN PICC WHICH WAS REMOVED AND REPLACED DUE TO LEAKING AT THE PURPLE HUB. THE USED DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5659242 ↗
• MalfunctionMay 6, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED PER BEDSIDE RN, LEAKING AT THE SITE OF THE PICC. VAD/PICC TEAM EVALUATED PICC LINE, ULTRASOUND WAS USED AND BASILIC VEIN WHICH HOUSES THE PICC IS PATENT AND COMPRESSIBLE. PURPLE PORT FLUSHES EASILY AND W/ GOOD BLOOD RETURN, WHITE PORT WHEN FLUSHING NOTICED SQUIRTING BY THE CLEAR EXTENSION TUBING NEAR THE STATLOCK AND Y JUNCTION. THE PICC WAS REMOVED AND REPLACED. PATIENT CONDITION WAS REPORTED AS "UNAFFECTED / STABLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5636901 ↗