BioFlo 45881Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI H965458810), received between Jun 9, 2016 and May 6, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Crack

  AN END USER REPORTED AN ISSUE WITH A BIOFLO PICC (VALVED) 4F SL 55CM IR-145 KIT WITH NITINOL GW PG WHEN ATTACHING A SYRINGE FOR FLUSHING. A CRACK WAS OBSERVED AT THE HUB PRIOR TO FLUSHING, AND NO FLUSHING WAS PERFORMED. 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 25104867 ↗
• MalfunctionMar 18, 2025Fracture; Fracture

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH PICC FROM A BIO-STABLE PICC (VALVED) 4F SL 55CM IR-145 KIT WITH NITINOL GW. THE CATHETER WAS SPLIT APPROXIMATELY 1.5CM ABOVE THE WING, THEREFORE IT WAS REMOVED. THE PATIENT WAS PUT ON ORALS SO NO REPLACEMENT WAS PERFORMED. IT WAS ALSO REPORTED THAT THEY USE SECURACATH AND THE NURSES ARE EDUCATED NOT TO USE SHARP OBJECTS AROUND LINES.THIS PATIENT WAS QUITE CHALLENGING WITH BEHAVIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631463 ↗
• MalfunctionDec 4, 2023Stretched; Migration; Stretched; Migration

  A CLINICAL SPECIALIST REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE PICC (VALVED) 4F SL 55CM IR-145 KIT, WITH NITINOL GW. THE PATIENT HAD A PICC INSERTION IN (B)(6) 2023. USES IT EVERY 4-6 HOURS FOR MEDS. IT WAS PUT IN AT A CERTAIN LENGTH THAT WAS WHERE IT NEEDED TO BE AND THE APPROPRIATE 3CM FROM SKIN ON THE OUTSIDE OF THE PATIENT FOR THE SECUREMENT DEVICE. SHE CAME BACK TO THE HOSPITAL FOR ISSUES WITH CHEST PAIN/ENZYME ELEVATION ISSUES. WITH SOME IMAGING IT SHOWED THAT THE PICC WAS SITTING WELL IN THE RIGHT VENTRICLE. DUE TO THIS ISSUE, THE PICC WAS REMOVED AND REPLACED WITH A NEW ONE, WHICH WAS CUT 1CM SHORTER THAN THE ORIGINAL PICC'S LENGTH TO BE SAFE. THE TUBING ON THE REMOVED PICC, AT THE PART THAT WAS INSIDE THE PATIENT, WAS NOTED TO BE A SLIGHTLY DIFFERENT COLOR THAN THE PORTION THAT WAS OUTSIDE THE PATIENT. IT WAS ALSO THOUGHT TO HAVE "FELT DIFFERENTLY". THE PICC WAS MEASURED AGAINST A MEASURING TAPE, MEASURING 46 CM EVEN THOUGH IT WAS CUT AT 40CM ACCORDING TO THE MARKINGS. IT SEEMS TO HAVE STRETCHED CONSIDERABLY AND THAT STRETCHING HAS CAUSED SOME PATIENT ISSUES. THE PATIENT WAS REPORTED AS STABLE AFTER THE PICC WAS REMOVED AND REPLACED.

  Patient problems: Pain

  MAUDE report 18255298 ↗
• MalfunctionMay 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE PICC (VALVED) 4F SL 55CM IR-145 KIT. IT WAS REPORTED THAT THERE WAS BLEED BACK FROM THE PICC DUE TO THE VALVE NOT WORKING CORRECTLY. THIS WAS NOTED DURING THE INITIAL PLACEMENT PROCEDURE WHEN PERFORMING A FLUSH. THE DEVICE WAS REMOVED AND REPLACED AND THERE WAS NO REPORT OF PATIENT HARM BY THE END USER. 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 11824415 ↗
• MalfunctionJan 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMCIS TM REPORTED AND END USER EXPERIENCED AN ISSUE WITH A BIOFLO PICC WITH PASV. THE PICC WAS ADVANCED OVER THE 145CM GUIDEWIRE TO PLACE THE PICC. WHEN WITHDRAWING THE GUIDEWIRE, THERE WAS A CONTINUOUS BLEED BACK OF BLOOD. THE AMOUNT OF BLOOD LOSS WAS REPORTED TO BE APPROXIMATELY <10ML. THE BLOOD FLOW WAS STOPPED BE REINSERTING THE GUIDEWIRE. THE GUIDEWIRE AND PICC WERE REMOVED AS ONE UNIT. A NEW OF THE SAME PICC WAS PLACED. THERE WAS NO SERIOUS HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11182951 ↗
• MalfunctionSep 21, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER(TM) REPORTED AN ISSUE WITH A BIOSTABLE PICC W/PASV. IT WAS REPORTED THAT THE PICC IS NORMALLY FIXATED WITH THE STATLOCK; HOWEVER, DUE TO THE ADHESIVE ON THE STATLOCK, THE PICC REQUIRED REMOVAL AND REPLACEMENT. THERE WAS NO PATIENT INJURY OR HARM DUE TO THIS EVENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFATURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10562383 ↗
• MalfunctionJun 23, 2020Difficult to Flush; Difficult to Flush

  ADDITIONAL INFORMATION PROVIDED BY THE USER STATED THE EVENT OCCURED DURING THE PICC PLACEMENT PROCEDURE AND THE PICC HAD NOT BEEN INDWELLING AS ORIGINALLY REPORTED. AS THE PICC DID NOT REQUIRE REMOVAL AND REPLACEMENT IN A FOLLOW UP PROCEDURE POST INDWELLING, THIS EVENT NO LONGER MEETS THE CRITERIA OF A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10184367 ↗
• InjuryDec 17, 2018Fracture; Migration; Fracture; Migration

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), DURING A PICC PLACEMENT PROCEDURE, "DOCTOR TRIED TO MANIPULATE THE GUIDEWIRE BUT NOTICE BUCKLING OF DISTAL GUIDEWIRE, ABOUT 1CM FROM THE DISTAL TIP. DOCTOR 'WITHDRAWN' THE GUIDEWIRE BUT GUIDEWIRE WAS BROKEN AND SHORT SEGMENT OF GUIDEWIRE WAS RETAINED INSIDE UPPER BRACHIAL VEIN. 'DOCTOR 'ATTEMPT' TO PERFORM ANOTHER PUNCTURE AT BRACHIAL VEIN AT CUBITAL FOSSA ARTERY WAS DONE WITH MIESO-PUNCTURE SET AND 5FR SHEATH WAS INSERTED'. THE RETAINED GUIDEWIRE WAS FINALLY RETRIEVED WITH FORCEPS ENDOVASCULARLY VIA THE 5FR SHEATH. NO RETAINED GW WAS NOTED AT RIGHT ARM AND CHEST AFTER RETRIEVAL CHECKED BY XRAY. PATIENT CONDITION WAS SAFE." IT HAS BEEN INDICATED THAT THE USED GUIDEWIRE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 8169471 ↗
• MalfunctionJun 4, 2018Occlusion Within Device; Occlusion Within Device

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), A PICC AS INSERTED IN THE RIGHT BASILIC VEIN FOR CHMOTHERAPY. THE DISTRICT NURSE WENT TO DO DRESSING 1 WEEK LATER. GOOD FLASHBACK. FLUSHED WITH 30 ML N-SALINE AND INJECTED 5 ML HEPARIN 500. ONE WEEK LATER PATIENT RETURNED TO ONCOLOGY. LINE BLOCKED. SENT TO RADIOLOGY. ASSESSED TO BE BLOCKED AND LINE REMOVED. PICC OUT UNTIL ABLE TO FLUSH. PICC COMPLETELY BLOCKED WITH CLOT TO HUB. PATIENT CONDITION WAS REPORTED TO BE "UNAFFECTED" BY THIS EVENT. THE USED PICC HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7564690 ↗
• InjuryMay 31, 2017Crack; Crack

  AS REPORTED BY HOSPITAL IN (B)(6), "DURING FLUSHING OF A 4F BIOFLO PASV PICC LINE AFTER INSERTION USING THE 10ML SYRINGE THAT COMES WITH THE PICC TRAY, BLOOD MIXED WITH NORMAL SALINE SPRAYED OUT THE SIDE OF THE SYRINGE AND INTO THE IR RESIDENT'S EYES, WHO WAS NOT WEARING PROTECTIVE EYE COVERING / MASK / FACE SHIELD. SHE IMMEDIATELY WAS TAKEN TO THE EYE WASH STATION. WHEN THE SUPERVISOR CHECKED THE SYRINGE, A CRACK WAS OBSERVED ALONG THE SIDE WITH THE VOLUME LABELING NUMBERS. NO FORCE WAS PUT ON THE SYRINGE PRIOR TO USE TO CAUSE A CRACK." IT HAS BEEN INDICATED THAT THE USED SYRINGE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6601479 ↗
• MalfunctionJun 9, 2016Detachment Of Device Component; Detachment Of Device Component

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), WHILE PLACING A PICC, THE USER TRIED TO PULL THE TEAR-AWAY SHEATH AND THE WINGS BROKE OFF. THE USER WAS FORCED TO REMOVE THE SHEATH OVER THE PICC LINE. ALL OF THE SHEATH WAS REMOVED, I.E., NO PATIENT COMPLICATIONS/INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5708820 ↗