BioFlo 45811Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI H965458110), received between Apr 19, 2016 and Jul 1, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Fluid/Blood Leak; Material Puncture/Hole

  A NEW ZEALAND DISTRIBUTOR REPORTED AN ISSUE WITH BIO-FLO 4F SL-55CM CATHETER KIT VALVED PG. IT WAS REPORTED THAT DURING CLINICAL USE, FLUID LEAKAGE WAS OBSERVED FROM THE EXTERNAL PORTION OF THE CATHETER TUBING. UPON CLOSER INSPECTION, A PINHOLE WAS DISCOVERED IN THE TUBING NEAR THE SECURACATH STABILIZATION DEVICE. DUE TO THE LOSS OF LINE INTEGRITY, THE DEVICE WAS REMOVED EARLIER THAN THE SCHEDULED TREATMENT PLAN REQUIRED. THERE WAS NO REPORTED PATIENT INJURY OR HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678442 ↗
• MalfunctionFeb 12, 2026Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL-55CM CATHETER KIT VALVED. IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS POST PLACEMENT, THE PICC WAS REMOVED AND REPLACED DUE TO A HUB CRACK. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322660 ↗
• MalfunctionNov 18, 2025Crack; Crack

  A SPECTRUM DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BIO-STABLE 4F SL-55CM CATHETER KIT VALVED. THE PICC'S HUB CRACKED, THEREFORE THE PICC WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583085 ↗
• MalfunctionOct 21, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BIO-STABLE 4F SL-55CM CATHETER KIT VALVED. WHEN FLUSHING THE PATIENT'S PICC, A SALINE LEAK WAS NOTICED TO BE COMING OUT OF THE CONNECTOR AND NEEDLEFREE DEVICE. THEY REMOVED THE NEEDLEFREE DEVICE AND NOTED A FRACTURE ALONG THE FUSION (HUB) OF THE DEVICE. THE PATIENT IS ON LONG-TERM TOTAL PARENTERAL NUTRITION IN WHICH HE SELF TREATS. DUE TO THIS ISSUE, THE PICC WAS REMOVED, AND REPLACED. IT WAS REPORTED THAT THERE WAS A DELAY IN HIS TREATMENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349658 ↗
• MalfunctionSep 2, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED WITH A BIO-STABLE 4F SL-55CM CATHETER KIT VALVED. THE END USER RETURNED THE PICC TO THE DISTRIBUTOR. IT WAS REPORTED THAT THE LEAK WAS NOTICED WHILST THE PICC WAS IN THE PATIENT DURING A ROUTINE FLUSH AND IT WAS REMOVED FOLLOWING THE LEAK BEING DISCOVERED. WHEN EXAMINED, IT WAS OBSERVED THERE WAS A LEAK ON THE BLUE PART OF THE LINE AROUND THE 5CM MARK. THERE WAS TAPE RESIDUE AT THAT POINT AS WELL. IT WAS THOUGHT THAT PERHAPS IT COULD HAVE BEEN CAUSED BY A NEEDLE OR SCALPEL. IT WAS REPORTED THAT THE PICC HAD BEEN REPLACED WITH A NEW OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22942909 ↗
• MalfunctionMay 16, 2025Material Puncture/Hole; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL-55CM CATHETER KIT VALVED. A PATIENT ATTENDED FOR PICC BLOODS PRIOR TO TREATMENT ON THE FOLLOWING MONDAY. ON FLUSHING THE PICC, THE STAFF NOTICED LEAKING FROM THE SITE. ON CHECKING IT CLOSELY THERE WAS A SMALL PUNCTURE NOTED IN THE PICC LINE, RIGHT AT THE TOP BEFORE THE WHITE CONNECTION AT THE END OF THE PICC. THE PICC WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034677 ↗
• MalfunctionApr 28, 2025Crack; Crack

  AN MIR REPORT WAS RECEIVED BY MHRA REPORTING AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 4F SL-55CM CATHETER KIT VALVED. IT WAS REPORTED THE PICC HUB WAS CRACKED AND LEAKING. THE PICC WAS REMOVED AND WILL BE REPLACED IN THE FOLLOWING WEEK. THE PATIENT HAS HAD THE SAME HAPPEN PREVIOUSLY. IT WAS THOUGHT TO HAVE BEEN CAUSED BY OVER TIGHTENING OF THE NEEDLE FREE CONNECTOR ONTO THE END OF THE PICC. ALL STAFF CARING FOR/USING PICC WERE ASKED TO BE VERY CAREFUL IN FUTURE WHEN SCREWING ON A NEW NFC OR GIVING SET (THE LATTER SCREWS INTO THE NFC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917301 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  SECOND REPORTED PICC (HUB DETACHED): A DISTRIBUTOR REPORTED THE FOLLOWING: "PATIENT HAS ALWAYS HAD A PICC LINE IN PLACE DUE TO DIFFICULT ACCESS, PATIENT WAS ADMITTED TO HOSPITAL DUE TO ABDOMINAL PAIN, WHILE IN HOSPITAL HER PREVIOUS PICC LINE BECAME BLOCKED, (THIS PICC LINE HAD BEEN IN PLACE FOR 9 MONTHS) IT WAS DECIDED TO PLACE A NEW PICC LINE FOR THE PATIENT. THE NEW LINE PLACED ON THE (B)(6) 2021 WITHOUT ANY ISSUES. ON THE 27/05/2021 I RECEIVED A PHONE CALL FROM THE WARD SAYING THAT PATIENTS PICC LINE HAD BROKEN, ON INSPECTION THE PURPLE HUB WAS COMPLETELY BROKEN FROM THE ACTUAL PICC LINE. STAFF HAD CLAMPED THE END AND SECURED LINE WITH A DRESSING. WHEN I ASKED THE PATIENT WHAT HAD HAPPENED, SHE SAID SHE WAS CLEANING HER TEETH AT THE SINK AND HEARD SOMETHING DROP ONTO THE FLOOR AND DISCOVERED IT WAS THE END OF HER PICC LINE. UNABLE TO GIVE THE PATIENT HER MEDICATION AS THIS HAPPENED AT THE NIGHT TIME, SO PATIENT WAS CANNULATED AND THEN REFERRED TO US IN THE MORNING. THIS PATIENT IS SMALL IN SIZE AND STATURE AND HER LINES ARE NORMALLY CUT BACK TO 34 CM. THIS LINE WAS CUT TO THIS LENGTH ON INSERTION HOWEVER ON REMOVAL THE MEDICAL TEAM ASKED IF WE WOULD CUT THE END TO SEND TO MICROB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968674 ↗
• MalfunctionJun 16, 2020Infusion or Flow Problem; Infusion or Flow Problem

  A DISTRIBUTOR REPORTED THAT AN END USER HAS EXPERIENCED INFUSION ISSUES WITH BIOSTABLE PICCS. IT WAS REPORTED THAT SOME BALLOON PUMPS HAVE NOT BEEN INFUSING COMPLETELY FOR CHEMOTHERAPY PATIENTS. THESE PUMPS INFUSE SLOWLY AT 2.5ML/HR - EQUIV TO 0.4167MLS/MIN (0.00694MLS/SECOND). A PHARMACY SUGGESTED TO THE END USER THAT WITH THE BALLOON PUMP FLOWING SO SLOWLY, ANY SLIGHT RESISTANCE MAY PROHIBIT INFUSION. WHEN THIS OCCURS, PATIENTS ARE NOT RECEIVING THEIR FULL INFUSION OF TREATMENT. THERE WAS NO REPORTED PATIENT HARM, ONLY POTENTIAL THAT THE PATIENT MAY HAVE NOT RECEIVED THEIR FULL INFUSION OF TREATMENT, THEREFORE THIS MEETS THE CRITERIA OF AN REPORTABLE EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Underdose

  MAUDE report 10157315 ↗
• MalfunctionFeb 12, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS PER NURSE: NOTICED DURING AN EXCHANGE THAT THE WHITE MARKINGS ON THE PICC, THAT IS OUTSIDE OF THE PATIENT'S BODY, HAD FLAKED OFF. PATIENT HAD THE PICC ONLY INSERTED FOR 1 WEEK. THE PICC WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THERE WAS NO PATIENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699594 ↗
• MalfunctionFeb 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PICC - VACUTAINER BROKE OFF IN THE HUB - USER HAD TO RE-INSERT ANOTHER PICC FOR A PATIENT WHO HAD A BLOOD SAMPLE TAKEN VIA THE PICC WHEN THE END OF THE VACUTAINER BROKE OFF THE HUB. THE PICC WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699587 ↗
• MalfunctionJun 17, 2019Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE UK, A PICC DEVICE FRACTURED AT THE SUTURE WING LOCATION. IT WAS ORIGINALLY STATED THAT THE FRACTURE OCCURRED DURING THE IMPLANTATION PROCEDURE, HOWEVER, EXAMINATION OF THE CONDITION OF THE RETURNED SAMPLE ON (B)(6) SHOWED THAT IT HAD BEEN IMPLANTED FOR A LENGTH OF TIME, THUS NEEDED TO BE REMOVED AND REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704891 ↗
• MalfunctionMay 20, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED BY A HOSPITAL IN (B)(6), THE INK MARKINGS ON MULTIPLE UNITS OF BIOFLO PICC DEVICES ARE ABLE TO BE RUBBED OFF DURING INSERTION AND/OR CLEANING. ONE PICC HAS BEEN REMOVED AND REPLACED (ALTHOUGH HOW LONG IT WAS IMPLANTED IS NOT KNOWN). THE USED PICC, AS WELL AS UNUSED UNITS FROM THE REPORTED PICC LOT, IS BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION. NO PATIENT INJURY OR COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624571 ↗
• MalfunctionJul 2, 2018Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED BY ANGIODYNAMICS DISTRIBUTOR IN (B)(6), PICC INSERTED ON (B)(6) 2018 WITH NO COMPLICATIONS. THE EXTENSION TUBE WAS CHANGED WEEKLY AS PER PROTOCOL. THE BIOFLO PICC WAS REPORTED LEAKING BY THE ONCOLOGY DEPT. ON (B)(6) 2018. WHEN THE PATIENT WAS SENT TO RADIOLOGY AND THE CATHETER WAS FLUSHED IT LEAKED AND WAS DRAWING BACK AIR RATHER THAN FLUID. ON INVESTIGATION, THE HUB OF THE PICC WAS CRACKED. THE PICC WAS REMOVED AND A NEW PICC WAS INSERTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7655365 ↗
• MalfunctionSep 13, 2017Fracture; Fracture

  AS REPORTED, PATIENT CAME INTO THE ER WITH A BROKEN PICC LINE (BROKEN AT THE EXTENSION LEG). THE DEVICE WAS REMOVED AND WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. THE PATIENT CONDITION WAS LISTED AS "UNAFFECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861396 ↗
• MalfunctionMar 10, 2017Fracture; Fracture

  AS REPORTED, PATIENT HAD BIOFLO PICC LINE REMOVED AND REPLACED DUE TO LEAKAGE AT THE EXTENSION LEG. PICC WAS PLACED ON (B)(6) 2017. PATIENT RELEASED TO HOME ON (B)(6) 2017 WITH PICC FOR ANTIBIOTICS. PICC REMOVED AND REPLACED ON (B)(6) 2017. NO PATIENT COMPLICATIONS REPORTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6394530 ↗
• MalfunctionMar 10, 2017Hole In Material; Hole In Material

  AS REPORTED, PATIENT HAD BIOFLO PICC LINE REMOVED AND REPLACED DUE TO LEAKAGE AT THE EXTENSION LEG. PICC WAS PLACED ON (B)(6) 2016. PATIENT RELEASED TO HOME ON (B)(6) 2016 WITH PICC FOR ANTIBIOTICS. PICC REMOVED AND REPLACED ON (B)(6) 2016. NO PATIENT COMPLICATIONS REPORTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6394528 ↗
• MalfunctionMay 18, 2016Fracture; Fracture

  INDWELLING PICC, PLACED ON (B)(6) WAS REMOVED ON (B)(6) DUE TO A CRACKED HUB. THE PICC HAD BEEN USED FOR CHEMOTHERAPY. 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 5663113 ↗
• MalfunctionMay 10, 2016Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. THE PATIENT CONDITION WAS REPORTED AS "STABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5644004 ↗
• MalfunctionApr 19, 2016Fracture; Fracture

  AS REPORTED BY (B)(4)' DISTRIBUTOR IN THE (B)(4), AN INDWELLING PICC WAS REMOVED DUE TO A CRACKED HUB. THE PATIENT CONDITION WAS REPORTED AS "STABLE." THE DEVICE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5587092 ↗
• MalfunctionApr 19, 2016Fracture; Fracture

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), AN INDWELLING PICC WAS REMOVED DUE TO A CRACKED HUB. THE PATIENT CONDITION WAS REPORTED AS "STABLE." THE DEVICE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5587076 ↗