BioFlo 45887Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI H965458870), received between Apr 28, 2016 and Apr 3, 2023 — classified as 1 injury, 10 malfunctions.

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

• MalfunctionApr 3, 2023Obstruction of Flow; Obstruction of Flow

  NEW INFORMATION PROVIDED: ON (B)(6) 2023, A PATIENT WAS ORDERED TO HAVE A PICC LINE CATHETER PLACED TO RECEIVE INTRAVENOUS ANTIBIOTICS AND CONTINUE TREATMENT AT HOME, AFTER DISCHARGE. THE RN PLACED THE PICC LINE IN THE BRACHIAL VEIN OF THE RIGHT ARM, WITHOUT PRESENTING ANY PROBLEM. AFTER THE PROCEDURE, A PORTABLE X-RAY OF THE THORAX WAS PERFORMED. THE PICC LINE WAS RUNNING WITH GOOD FLOW. ON (B)(6) 2023, THE NURSE FOLLOWED UP ON THE PATIENT, AND WAS NOTIFIED BY THE NURSE IN CHARGE THAT THE PICC LINE WAS NOT WORKING PROPERLY. THE CATHETER WAS NOT IRRIGATING CORRECTLY AND THE FLOW DECREASED SLOWLY OR AT INTERVALS. THE NURSE PROCEEDED TO REPOSITION THE PICC LINE UNDER ASEPTIC TECHNIQUES, WITH A WIRE 0.18, AND IT WAS FUNCTIONAL. ON (B)(6) 2023, THE NURSE DID ANOTHER FOLLOW-UP ROUND AND THE NURSE IN CHARGE OF THE PATIENT NOTIFIED HER THAT THE PICC LINE HAD PROBLEMS DURING THE ADMINISTRATION OF MEDICATIONS, IT ONLY WENT DOWN WHEN THE INTRAVENOUS INFUSION MACHINE WAS USED. ON (B)(6) 2023, THE PICC LINE WAS NOT FLOWING WELL AND WAS REMOVED, THE NURSE INSERTED ANOTHER PICC LINE INTO THE BRACHIAL VEIN OF THE LEFT ARM. CURRENTLY THE PATIENT REMAINS HOSPITALIZED RECEIVING INTRAVENOUS ANTIBIOTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662512 ↗
• MalfunctionApr 3, 2023Obstruction of Flow; Obstruction of Flow

  NEW INFORMATION RECEIVED: ON (B)(6) 2023, PATIENT HAD A DOCTOR'S ORDER FOR A PICC LINE TO RECEIVE INTRAVENOUS ANTIBIOTICS IN THE HOSPITAL AND AT HOME AFTER DISCHARGE. THE RN PROCEEDED TO CANNULATE WITH THE BIOFLO PICC LINE, MEASURING 44 CM, THE BRACHIAL VEIN OF THE LEFT ARM WITHOUT ANY PROBLEM. AFTER THE PROCEDURE, A PORTABLE CHEST PLATE WAS DONE AND THE PICC LINE WAS WORKING PROPERLY. ON (B)(6), THE PATIENT WAS DISCHARGED WITH THE PICC LINE IN PLACE. ON (B)(6), A FAMILY MEMBER BROUGHT PATIENT TO EMERGENCY ROOM REPORTING THAT THE PICC LINE WAS NOT FLOWING WELL, SINCE SATURDAY, (B)(6). THE NURSE EVALUATED THE PICC LINE AND NOTIFIED THE DOCTOR THAT THE PICC LINE WAS NOT WORKING. THE DOCTOR SCHEDULED THE PATIENT ON (B)(6), TO VERIFIED THE PICC LINE FOR A POSSIBLE CHANGE. ON (B)(6), THE PICC LINE WAS REPOSITIONED UNDER ASEPTIC TECHNIQUES WITH A 0.18 MM WIRE AND IT WAS WORKING PROPERLY. BEFORE THE PATIENT WAS DISCHARGED, THE PICC LINE WAS EVALUATED AND IT PRESENTED IRRIGATION PROBLEMS. THE DOCTOR WAS NOTIFIED, HE TOOK THE PATIENT TO THE CARDIOVASCULAR LAB FOR A FLUOROSCOPIC EVALUATION. THE PICC LINE DIDN'T WORK AND THE DOCTOR INSERTED ANOTHER ONE. THE PATIENT WAS DISCHARGED HOME WITHOUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662507 ↗
• MalfunctionNov 4, 2022Material Twisted/Bent; Material Twisted/Bent

  AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM IR-145 KIT, NON-VALVED, WITH NITINOL GW PG. IT WAS REPORTED THAT, APPROXIMATELY 10 MINUTES POST PLACEMENT OF THE PICC LINE, THE NURSE WAS ABLE TO FLUSH THE DEVICE BUT WAS UNABLE TO ASPIRATE. WHEN THE PICC WAS PLACED THERE WAS NO NOTICEABLE PINCHING OF THE TUBING BELOW THE HUB. THE CATHETER WAS REPORTED TO BE PINCHING WHERE IT CONNECTED TO THE HUB. THE PATIENT'S POSITIONING WAS MANIPULATED FOR 20 MINUTES BUT DID NOT RESOLVE THE ISSUE. IT WAS REPORTED THAT NO TYPE OF SECUREMENT OF THE HUB TO THE PATIENT USED TO PREVENT THE HUB FROM MOVEMENT. THE PICC WAS REMOVED AND REPLACED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734773 ↗
• MalfunctionMar 3, 2022Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM IR-145 KIT. DURING THE PLACEMENT PROCEDURE, THE END USER EXPERIENCED DIFFICULTY RETRACTING THE GUIDEWIRE AND HAD TO APPLY FORCE. THIS RESULTED IN THE TIP OF THE GUIDEWIRE DETACHING, APPROXIMATELY 8CM, INTO ONE OF THE LUMENS. THIS WAS DISCOVERED VIA X-RAY. AS A RESULT OF THIS INCIDENT, THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER PICC WAS PLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659532 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM IR-145 KIT NON-VALVED WITH NITINOL GW PG. A FEW MONTHS AFTER PLACEMENT, WHILE THE NURSE WAS FLUSHING THE DEVICE PRIOR TO CHEMOTHERAPY, IT WAS NOTED TO BE LEAKING. AFTER CONSULTATION WITH A PHYSICIAN, THE DECISION WAS MADE TO REMOVE THE PICC. IT WAS EXAMINED AND THE LEAK WAS FOUND TO BE ORIGINATING FROM THE 10CM MARKING. THE PICC WAS REMOVED AND REPLACED. THE PATIENT'S CHEMOTHERAPY TREATMENT WAS TEMPORARILY POSTPONED UNTIL THE REPLACEMENT PICC WAS PLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539345 ↗
• MalfunctionMay 10, 2021Unraveled Material; Unraveled Material

  AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 5F DL-55CM IR-145 KIT. DURING A PROCEDURE, THE GUIDEWIRE WAS DIFFICULT TO REMOVE FROM THE PICC. WHEN REMOVED, THE SOFT END OF THE WIRE UNRAVELED AND BROKE INSIDE THE PICC LINE, NEAR THE HUB OF THE CATHETER. THE DOCTOR WAS ABLE TO ADVANCE ANOTHER WIRE INTO THE SECOND PORT AND REMOVE THE CATHETER, WITH THE BROKEN WIRE TIP REMAINING INSIDE OF THIS DEVICE. THE CATHETER APPEARED TO BE KINKED NEAR THE HUB. ANOTHER SAME DEVICE WAS PLACED SUCCESSFULLY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT 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 11796825 ↗
• MalfunctionMar 9, 2020Fracture; Fracture

  AS REPORTED: THE PATIENT HAVE HAD A NEWLY DIAGNOSED LEUKEMIA. HE HAD A THROMBOSIS IN THE LEFT ARM WITH ANOTHER PICC BRAND. THE NURSE IMPLANTED A BIOFLO PICC CATHETER IN THE OTHER ARM (RIGHT ARM), AND WHEN SHE PUT SHE PICC OVER THE WIRE AND SHE TRIED TO REMOVE THE WIRE IT WAS IMPOSSIBLE. SHE PULLED OUT THE WIRE BUT IT WAS A LOT OF RESISTANCE AND THEN THE WIRE BROKE. SHE THOUGHT THE FLOPPY OF WIRE WAS IN THE ATRIUM, BUT IT WAS LOCATED INSIDE TO THE BIOFLO PICC TUBING . NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9805820 ↗
• MalfunctionDec 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  PATIENT 1: AS REPORTED FROM ANGIODYNAMICS' DISTRIBUTOR: ONE OF THE HOSPITALS THAT ARE EVALUATING AT THE PRESENT TIME HAVE EXPERIENCED 2 BLOCKAGES. THEY ARE THE SAME PICCS; 5FR DL, LOT NUMBER 5502057. THE CUSTOMER ASSURES ME THAT THE CARE AND MAINTENANCE FOR THESE PICCS HAS NOT CHANGED. THERE HAS BEEN NO POLICY CHANGE AROUND PICC LINES. ONE PATIENT HAS THEIR PICC FOR IVAB AND IVF. THE OTHER PATIENT IS IN HDU WITH PANCREATITIS. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT IS UNKNOWN AT THIS TIME IF THE DEVICE IS AVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9504052 ↗
• MalfunctionDec 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  PATIENT 2: AS REPORTED FROM ANGIODYNAMICS' DISTRIBUTOR: ONE OF THE HOSPITALS THAT ARE EVALUATING AT THE PRESENT TIME HAVE EXPERIENCED 2 BLOCKAGES. THEY ARE THE SAME PICCS; 5FR DL, LOT NUMBER 5502057. THE CUSTOMER ASSURES ME THAT THE CARE AND MAINTENANCE FOR THESE PICCS HAS NOT CHANGED. THERE HAS BEEN NO POLICY CHANGE AROUND PICC LINES. ONE PATIENT HAS THEIR PICC FOR IVAB AND IVF. THE OTHER PATIENT IS IN HDU WITH PANCREATITIS. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. IT IS UNKNOWN AT THIS TIME IF THE DEVICE IS AVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9504050 ↗
• MalfunctionMar 21, 2017Malposition of Device; Malposition of Device

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), PATIENT HAD PICC INSERTED FOR CHEMOTHERAPY ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS GIVEN A CONTRAST INJECTION AT 4MLS PER SEC CALIBRATED AT UNDER-RECOMMENDED PSI PRESSURE. THE PRE-CONTRAST SCAN SHOWED ACCEPTABLE TIP POSITION OF THE PICC - SVC/RA JUNCTION. FOLLOWING THE INJECTION THE PICC TIP WAS POSITIONED IN THE SVC JUST BELOW THE LEVEL OF THE AZYGOS. ON THE POST-SCAN A SMALL EXTRAVASATION OF 5-10ML WAS ALSO NOTED (CONTRAST LOCATED IN A MINOR VESSEL, NOT DISPERSED). THE PATIENT REMAINED ASYMPTOMATIC DURING AND POST SCAN AND DID NOT REQUIRE ANY FURTHER MEDICAL INTERVENTION DUE TO THIS EVENT. THE PICC WAS REMOVED AND HAS BEEN RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6420207 ↗
• InjuryApr 28, 2016Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORT CALLED IN BY PATIENT . HAS PREVIOUSLY HAD 3 BIOFLO PICCS IN PLACE WITH NO ISSUES. A 4TH. PICC WAS PLACED ON (B)(6) 2016 IN THE IR AT (B)(6) MC IN (B)(6). IT WAS PLACE ON THE PATIENT'S RIGHT SIDE CHEST AND TUNNELED IN PLACE. THE PATIENT IS COMPLAINING OF HER SKIN BEING SWOLLEN AND REDNESS IN THE TUNNELED REGION. SHE SAID SHE HAD "BEEN VERY SICK" SINCE THE PLACEMENT PROCEDURE AND WANTED TO SEE IF THIS WAS CAUSED BY ANY MATERIALS IN THE NEW PICC. THERE ARE MANY OTHER FACTORS THAT COULD BE CAUSING HER ILLNESS, WANTED TO RULE OUT THE PICC, ITSELF.

  Patient problems: Skin Inflammation; Swelling

  MAUDE report 5616531 ↗