BioFlo 75033Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI H965750330), received between Oct 18, 2017 and Oct 11, 2021 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2021Fracture; Fracture

  A NURSE REPORTED AN ISSUE WITH A BIOFLO PICC (NV) 5FDL-55CM MAXIMAL BARRIER NURSING KIT W/70CM NITINOL WIRE. POST PROCEDURE, THE PICC WAS FOUND TO HAVE "SPLIT" WHERE THERE APPEARED TO BE A KINK AT THE 6CM MARK, WHILE IN THE PATIENT'S ARM. THE PATIENT REPORTED SOME PAIN UPON FLUSHING, BUT THE FLUSHING DID NOT CAUSE ANY HARM TO THE PATIENT. THE LINE WAS D/C'D WHEN PATIENT REPORTED PAIN WITH INJECTION. THE PICC WAS REMOVED AND WAS REPLACED WITH A PIV. THE PATIENT ONLY HAD THE PICC FOR 8 DAYS AND THE NURSE REPORTED NOT KNOWING HOW MUCH HANDLING AND MANIPULATION THE DEVICE HAD RECEIVED PRIOR TO HER NOTICING THE KINK AND SPLIT IN THE CATHETER. THERE WAS NO PATIENT HARM OR ADVERSE EVENT 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; Pain

  MAUDE report 12605298 ↗
• InjuryAug 14, 2019Unintended Movement; Unintended Movement

  AS REPORTED BY THE CUSTOMER: A FLIPPED/COILED LINE IN A PATIENT. DEVICE WAS SUCCESSFULLY REMOVED, AND TH PATIENT WAS REPORTED AS UNAFFECTED. 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 8893025 ↗
• InjuryAug 23, 2018Crack; Crack

  THE LINE COMPANY, A MOBILE PICC TEAM REPORTED THAT THEY GOT A CALL FROM ONE OF THEIR CUSTOMERS STATING THAT PIECE OF GUIDEWIRE (USED TO PLACE A PICC) MAY HAVE BROKEN OFF INTO A PATIENT'S BODY. NOTIFICATION THAT THEY RECEIVED READ, "(B)(6) 2018 XRAY LINEAR RADIODENSITY OVERLYING THE PULMONARY ARTERY. ON (B)(6) 2018 XRAY NOTES 2 CM BROKEN WIRE FOREIGN BODY IN THE PULMONARY ARTERY UNCHANGED FROM (B)(6)." THE FAMILY OF THE PATIENT DID NOT WISH TO HAVE THE GUIDEWIRE FRAGMENT REMOVED. THE MOBILE PICC GROUP WAS NOTIFIED ON 7/26/2018. THEY UNDERSTAND THAT THE PATIENT INVOLVED ALSO HAD A PICC LINE (MANUFACTURER UNKNOWN) PLACED AT ANOTHER HOSPITAL. THEY ARE NOTIFYING ALL MANUFACTURERS WHOSE PICCS WERE USED ON THIS PATIENT. THE LINE COMPANY PLACED 5 BIOFLO PICCS (FROM 3 DIFFERENT PRODUCT LOTS) IN THE TIME FRAME BETWEEN (B)(6) AND (B)(6) 2018.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7808942 ↗
• MalfunctionJun 21, 2018Fracture; Fracture

  BIOFLO PICC, WHICH HAD BEEN ORIGINALLY PLACED ON (B)(6) 2017, WAS REMOVED AND REPLACED ON (B)(6) 2018 DUE TO A CRACKED HUB. NO PATIENT COMPLICATIONS OR INJURY WAS REPORTED. THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625987 ↗
• InjuryJun 12, 2018Crack; Crack

  AS REPORTED, DURING PLACEMENT OF A PICC, THE GUIDEWIRE "SNAPPED" WHILE IN THE PATIENT." THERE WAS NO TRAUMA TO THE PATIENT, AND THE WIRE WAS SUCCESSFULLY REMOVED. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYANAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7591588 ↗
• MalfunctionNov 15, 2017Fracture; Fracture

  AS REPORTED, PICC WHICH HAD BEEN IN PATIENT'S ARM WAS REMOVED AND REPLACED ON THE THIRD DAY OF USE BECAUSE OF A CRACKED HUB. NO PATIENT INJURY WAS REPORTED. THE USED CATHETER WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7032775 ↗
• MalfunctionOct 31, 2017Difficult to Flush; Difficult to Flush

  AS REPORTED, 5F BIOFLO PICC "USED ON SMALL VESSELS UPON ASSESSMENT - UPPER ARMS." INITIAL INSERTION ON (B)(6) 2017 BY PICC RN. NO BLOOD RETURN OR FLUSHING FUNCTION WAS NOTED 12 HOURS AFTER INSERTION. PICC WAS REMOVED AND EXCHANGED AT THE SAME SITE BY IR MD UNDER FLUORO ON (B)(6) 2017. THE INITIAL PICC WAS EXAMINED AT THE HOSPITAL AND DID NOT HAVE ANY DEBRIS INSIDE. IT FLUSHED WELL OUTSIDE THE PATIENT. IT WAS ALSO FREE OF ANY THROMBIN/CLOT ADHESION ON THE EXTERNAL PARTS OF THE PICC. CATHFLO HAD BEEN UTILIZED. THE REMOVED PICC WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990807 ↗
• MalfunctionOct 31, 2017Difficult to Flush; Difficult to Flush

  AS REPORTED, 5F BIOFLO PICC "USED ON SMALL VESSELS UPON ASSESSMENT - UPPER ARMS." PICC WAS PLACED (AS A REPLACEMENT) BY IR MD UNDER FLUORO ON (B)(6) 2017. AFTER 10-12 HOURS THE PICC BEGAN TO HAVE NO BLOOD RETURN OR FLUSHING FUNCTION (SIMILAR TO WHAT HAD OCCURRED WITH THE PICC THAT THIS PICC HAD REPLACED). IT WAS DECIDED TO BE REMOVED ON (B)(6) 2017. THE IR MD THEN PLACED A TUNNELED PICC INTO THE RIGHT IJ/CHEST ON (B)(6) 2017. THE INITIAL PICC WAS EXAMINED AT THE HOSPITAL AND DID NOT HAVE ANY DEBRIS INSIDE. IT FLUSHED WELL OUTSIDE THE PATIENT. IT WAS ALSO FREE OF ANY THROMBIN/CLOT ADHESION ON THE EXTERNAL PARTS OF THE PICC. CATHFLO HAD BEEN UTILIZED. THE REMOVED PICC WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990804 ↗
• MalfunctionOct 18, 2017Fracture; Fracture

  AS REPORTED, PICC WAS PLACED ON (B)(6) 2017, REMOVED AND REPLACED ON (B)(6) 2017 DUE TO A CRACK IN THE HUB. THE PATIENT WAS ON ECMO AND KEPT GETTING AIR PULLED INTO THE SVC/ECMO SYSTEM UNTIL THEY FIGURED OUT WHERE THE AIR WAS COMING FROM. THE HOSPITAL NOTED THAT, "SOMEONE MAY HAVE USED HEMOSTATS WHEN CONNECTING OR DISCONNECTING THE PICC," THEREBY CAUSING THE CRACKED HUB. THE USED CATHETER WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6957768 ↗