BioFlo 45832Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI H965458320), received between Mar 28, 2016 and Dec 24, 2025 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Crack; Crack

  AN END USER REPORTED AN ISSUE WHEN USING THE BIO-FLO 5F DL 55CM MST-70 KIT 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 23887823 ↗
• MalfunctionAug 8, 2025Crack; Crack

  AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO 5F DL 55 CM MST-70 KIT VALVED. IT WAS REPORTED POST-PLACEMENT THAT THE PICC HUB CRACKED, REQUIRING REMOVAL. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22758676 ↗
• MalfunctionJan 16, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 5F DL 55CM MST-70 KIT VALVED. IT WAS REPORTED THE GREY LUMEN WAS NOTED TO BE CRACKED AND WAS LEAKING 52 DAYS POST INSERTION. THE PICC WAS IN USE FOR TPN. THE PICC WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168365 ↗
• MalfunctionJan 16, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 5F DL 55CM MST-70 KIT VALVED. IT WAS REPORTED THE GREY LUMEN WAS NOTED TO BE CRACKED ON DAY 23 OF INDWELL AND WAS LEAKING. THE PICC WAS IN USE FOR TPN. THE PICC WAS REMOVED AND REPLACED.THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168364 ↗
• MalfunctionJul 2, 2024Crack; Crack

  A DISTRIBUTOR REPORTED, AN END USER EXPERIENCED. AN ISSUE WITH A PICC FROM A BIO-STABLE 5F DL, 55CM MST-70 KIT VALVED. IT WAS REPORTED, THAT 25 DAYS POST PLACEMENT, THE HUB OF THE PICC WAS NOTED, TO BE CRACKED. THE PICC WAS REPLACED IN ORDER FOR THE PATIENT TO CONTINUE THE TPN TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656269 ↗
• MalfunctionJun 3, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED THEY HAD AN END USER REPORT A PROBLEM WITH A PICC FROM A BIO-STABLE 5F DL 55CM MST-70 KIT VALVED. THE END USER REPORTED: THE FEMALE PATIENT WAS ON TPN GIVEN VIA THE WHITE LUMEN, AND ON DAY 62, IT WAS REPORTED THAT THE WHITE LUMEN WAS CRACKED AND TPN WAS LEAKING. THEY HAD TO REPLACE IT WITH A NEW DL PICC. THE CUSTOMER CUT THE LINE AFTER REMOVAL IN ORDER TO EXAMINE IT AND WAS ABLE TO CLEARLY SEE WHERE THE LUMEN WAS CRACKED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446662 ↗
• MalfunctionJun 29, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 5F DL 55CM MST-70 KIT. A PATIENT WAS ADMITTED IN AE (B)(6) 2021 WITH HAEMOPTYSIS AND ABDOMINAL PAIN. ON (B)(6) 2021 A DOUBLE LUMEN PICC WAS INSERTED FOR USE WITH TPN DUE TO GASTRIC OUTLET OBSTRUCTION. POST PROCEDURE, ON (B)(6) 2021, A LEAK WAS NOTED. ON (B)(6) 2021, UPON CLOSER INSPECTION OF THE PICC LINE, IT WAS NOTED THE WHITE TPN LUMEN HAD A HAIRLINE FRACTURE. THE LUMEN WAS BEING USED FOR ADMINISTRATION OF TPN. THERE WAS NO DOCUMENTATION OF EXCESSIVE FORCE BEING APPLIED NOR TO THE PATIENT'S RECALL. A BBRAUN CARESITE NEEDLEFREE CONNECTOR WAS USED AND WAS REPORTED TO BE LEAKING, PRIOR TO ASSESSMENT. AFTER THE FRACTURE WAS DISCOVERED, THE PATIENT OPTED TO KEEP THE PICC LINE IN PLACE UNTIL LINE REMOVAL UPON DISCHARGE. THE RISKS OF LEAVING A FRACTURED PICC LINE IN PLACE WAS EXPLAINED TO THE PATIENT. THE PICC WAS REMOVED ON (B)(6) 2021. IT WAS NOT REPLACED AT THAT TIME. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086642 ↗
• MalfunctionNov 21, 2019Crack; Crack

  AS REPORTED: (PHOTO OF DEFECT WAS PROVIDED BY THE USER) THE IMAGE DOES SHOW CLEARLY THE CRACK (THE SYRINGE IS MY ADDITION TO OPEN UP THE CRACK TO PHOTO) - I CAN SAY THAT THE TWO LUERS HAD DEVICES ATTACHED WHICH WERE BOTH VERY TIGHTLY APPLIED. THE ATTACHED PARTS CAN BE SEEN ON IMAGE. THE REPORT FROM THE MEDICAL PROFESSIONAL SAID: CRACKED PICC ON LUMEN USED FOR TPN. 5FR PICC WAS INSERTED FOR PARENTERAL NUTRITION ON (B)(6) 2019. DAY 59 OF TREATMENT IT WAS NOTED THAT WHITE LUMEN HAD VISIBLE CRACK AND WAS LEAKING. PN WAS SWITCHED TO ALTERNATE LUMEN UNTIL PICC COULD BE REWIRED. PICC WAS SUCCESSFULLY REWIRED ON (B)(6) 2019 AND FAULTY PICC RETAINED FOR INVESTIGATION. NECESSITATED PATIENT UNDERGOING ANOTHER PROCEDURE TO HAVE THE PICC REPLACED AND DELAY IN PATIENT RECEIVING PARENTERAL NUTRITION AS BAG HAD TO BE WASTED ONCE CRACK IN LUMEN DISCOVERED. NO MEDICAL INTERVENTION REQUIRED. NO PATIENT INJURY OR HARM DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355765 ↗
• MalfunctionJan 29, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4), INDWELLING BIOFLO PICC WAS REMOVED DUE TO A CRACKED HUB. PICC WAS BEING USED FOR THE DELIVERY OF TPN. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285041 ↗
• MalfunctionJan 29, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' (B)(4), INDWELLING BIOFLO PICC WAS REMOVED DUE TO A CRACKED HUB. PICC WAS BEING USED FOR THE DELIVERY OF TPN. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285038 ↗
• MalfunctionJan 29, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' (B)(4), INDWELLING BIOFLO PICC WAS REMOVED DUE TO A CRACKED HUB. PICC WAS BEING USED FOR THE DELIVERY OF TPN. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285037 ↗
• InjuryAug 9, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4): "BEDSIDE PLACEMENT OF DOUBLE LUMEN 5 FRENCH PICC IN SIDE ROOM OF HAEMATOLOGY WARD. LAND MARK MEASURING TECHNIQUE WITH RADIOLOGICAL TIP VERIFICATION. NEEDLE PLACED IN LEFT BASILIC VEIN UNDER ULTRASOUND GUIDANCE ON FIRST ATTEMPT, THIS WAS A LARGE STRAIGHT VEIN AT DEPTH APPROXIMATELY 2-3 CM. ON ULTRASOUND THE NEEDLE TIP WAS EASY TO SEE AND PLACED CENTRALLY IN THE VEIN WITH GOOD VENOUS RETURN. GUIDEWIRE ADVANCE SLOWLY IN 2-3 CM INCREMENTS TO APPROXIMATELY 20 CM WHEN IT MET SOME RESISTANCE AND WAS PULLED BACK, THE GUIDEWIRE CONTINUED TO MOVE FREELY WITHIN VEIN. MICRO-INTRODUCER PASSED EASILY FIRST ATTEMPT, GUIDEWIRE STILL MOVING FREELY IN VEIN. ATTEMPTED REMOVAL OF GUIDEWIRE THROUGH MICRO-INTRODUCER UNSUCCESSFUL DUE TO RESISTANCE. REMOVAL OF GUIDEWIRE WITH INTRODUCER ATTEMPTED BUT UNSUCCESSFUL. REMOVAL OF GUIDEWIRE WITH MICROINTRODUCER AND PEELAWAY SHEATH ATTEMPTED BUT UNSUCCESSFUL. AT THIS POINT THE GUIDEWIRE COULD STILL BE MOVED WITHIN THE VEIN HOWEVER ON GENTLY PULLING BACK TO ASSESS THE INTERNAL LENGTH IT BECAME STUCK, THERE WAS APPROXIMATELY 60 CM LENGTH EXTERNALLY. A CONSULTANT INTERVENTIONAL RADIOLOGIST ATTEMPTED TO REMOVE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7769158 ↗
• InjuryJul 31, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6): "NURSES IN CHEMOSUITE ATTEMPTED TO REMOVE PICC FOLLOWING COMPLETION OF CHEMO (B)(6) 2018. UNFORTUNATELY, IT BECAME STUCK WITH 17.5 CM REMAINING INSIDE. HEAT, MASSAGE AND UROKINASE WERE USED TO NO AVAIL. PATIENT HAD NO ISSUES WITH PICC DURING USAGE. PATIENT RETURNED (B)(6) 2018 AND IT WAS ATTEMPTED TO REMOVE PICC AGAIN BUT USING A GUIDEWIRE BUT COULD SEE OBVIOUS TETHERING AT HER AXILLA. PATIENT WAS REFERRED TO THE INTERVENTIONAL RADIOLOGISTS AT MOUNT VERNON, WHERE IT WAS REMOVED ON (B)(6) 2018. THREE REMOVAL ATTEMPTS BY CLINICIANS, DISCOMFORT AND INCONVENIENCE FOR PATIENT. THE USED DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Discomfort

  MAUDE report 7736308 ↗
• InjurySep 13, 2017Crack; Uncoiled; Crack; Uncoiled

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), DURING A PICC PLACEMENT, INTIAL ACCESS TO THE VEIN WENT WITHOUT DIFFICULTY AND THERE WAS GOOD BLOOD RETURN. WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE, THERE WAS RESISTANCE. THE NEEDLE WAS THEN REMOVED, AND THE GUIDEWIRE REMAINED STUCK. THE GUIDEWIRE UNCOILED AND THEN SNAPPED, LEAVING ONLY 1 INCH EXTERNALLY. THE GUIDEWIRE WAS EVENTUALLY ABLE TO BE REMOVED AFTER A CUT-DOWN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6861391 ↗
• MalfunctionJan 27, 2017Uncoiled; Uncoiled

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), A DURING A PICC PLACEMENT PROCEDURE, THE GUIDEWIRE WAS INSERTED UP TO 35CM WITHOUT RESISTANCE OR PROGRESSION DIFFICULTIES. THE DILATOR WAS THEN INTRODUCED AND WHILE RETRIEVING THE GUIDEWIRE RESISTANCE WAS FELT AT 30 CM. THE PATIENT'S LIMB WAS MANIPULATED AS WELL AS LATERALIZATION, WITHOUT SUCCESS. THE WIRE WAS SPUN 360 DEGREES TO THE RIGHT AND LEFT FOR AN HOUR IN ORDER TO RETRIEVE IT. ONCE REMOVED, THE GUIDEWIRE APPEARED TO HAVE UNWOUND, BUT X-RAY IMAGES DID NOT SHOW THAT ANY PORTION HAD DETACHED AND REMAINED IN THE PATIENT. THE PICC WAS EVENTUALLY PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6282381 ↗
• MalfunctionJan 9, 2017Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), "THE LUMEN OF A 5F BIOFLO PICC THROUGH WHICH PARENTERAL NUTRITION WAS BEING DELIVERED CRACKED ON DAY 19 OF USE." NO PATIENT COMPLICATIONS WERE REPORTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233505 ↗
• MalfunctionNov 29, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), " LUMEN OF A 5FR. BIOFLO PICC THROUGH WHICH PARENTERAL NUTRITION WAS BEING DELIVERED CRACKED ON DAY 19 OF USE." THE DEVICE WAS REMOVED AND REPLACED. 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 6131424 ↗
• MalfunctionNov 18, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6) , AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. THERE WAS NO REPORTED PATIENT INJURY. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6114298 ↗
• MalfunctionAug 10, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4), AN INDWELLING PICC WAS REMOVED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT WAS STATED THAT THE USED DEVICE WOULD BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5864492 ↗
• MalfunctionAug 10, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), A PICC DEVICE WAS REMOVED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATIONS WERE INDICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5864480 ↗
• MalfunctionMay 18, 2016Fracture; Fracture

  INDWELLING PICC, PLACED ON (B)(6) WAS REMOVED ON (B)(6) DUE TO A CRACKED HUB. IT WAS NOT STATED THAT THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. THE USED DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5663135 ↗
• MalfunctionApr 19, 2016Fracture; Fracture

  AS REPORTED BY (B)(4)' DISTRIBUTOR IN THE (B)(4): "DOUBLE LUMEN PICC PLACED FOR PARENTERAL NUTRITION ON (B)(6) 2016. PURPLE LUMEN DEDICATED FOR ADMINISTRATION OF PARENTERAL NUTRITION WITH ICU MEDICAL TPN BUNG. WHITE LUMEN USED FOR INTRAVENOUS ANTIBIOTIC AND FLUIDS WITH BIONECTOR NEEDLE FREE CONNECTOR. ON ATTEMPTING TO REPLACE THE BIONECTOR ON THE WHITE LUMEN THE PURPLE HUB SECTION WAS REPORTED TO SHATTER AND BREAK OFF LEAVING A SMALL SEGMENT AND THE CATHETER OPEN ENDED. THE CATHETER WAS IMMEDIATELY REMOVED AND REQUIRED REPLACEMENT." NO PATIENT INJURY WAS REPORTED. THE USED DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5587107 ↗
• MalfunctionApr 12, 2016Crack; Crack

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), PICC PLACED ON (B)(6)2015 WAS REMOVED AND REPLACED DUE TO LEAKAGE AT THE LUER HUB. THE HUB WAS DETERMINED TO BE CRACKED. A LUER SLIP SYRINGE HAD BEEN USED FOR MAINTENANCE. ICE MEDICAL TPN NEEDLELESS CONNECTOR WAS USED AT THE OUTSET. THE LUMEN WAS USED FOR PN. NO PATIENT COMPLICATIONS WERE REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5571048 ↗
• InjuryMar 28, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6): INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. THE PATIENT ALSO REPORTED HAVING SWELLING IN THE LEFT ARM WHICH HAD THE PICC IN SITU WITH PITTING ODEMA WITH AN UPPER CIRCUMFERENCE OF 45CM COMPARED TO THE RIGHT ARM WHICH MEASURED 33CM. DOPPLER ON THE LEFT ARM DIAGNOSED A THROMBOSIS WHICH IS BEING TREATED WITH ANTITHROMBOLYTICS. THE PATIENT DID NOT HAVE RISK FACTORS FOR THROMBOSIS, NEITHER IS HE RECEIVING CHEMOTHERAPY. PATIENT HAS A PORT-CATH IN SITU WHICH IS FUNCTIONING WELL. PER COMPLAINT REPORTER, "THROMBOSIS IS ONE OF THE SIDE EFFECTS WE DISCUSS WITH PATIENTS WHEN CONSENTING FOR PICCS." IT IS NOT IMPLIED THAT THE CRACK IN THE HUB OF THE PICC WAS THE CAUSE OF THE THROMBOSIS.

  Patient problems: Thrombosis

  MAUDE report 5529402 ↗