BioFlo 45895Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H965458950), received between Mar 20, 2018 and Mar 4, 2026 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Infusion or Flow Problem

  A SPECTRUM DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIOFLO 5F DL-55CM MST-70 KIT NON-VALVED WITH NITINOL GUIDEWIRE BRAZIL. IT WAS REPORTED THAT THERE WAS DIFFICULTY EXTRAVASATING CONTRAST FROM THE CATHETER POSSIBLE DUE TO IMPROPER POSITIONING. DUE TO THIS ISSUE, THE PICC WAS REMOVED AND REPLACED. THERE IS NO REPORT OF PATIENT HARM, OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505714 ↗
• InjuryJun 12, 2018Physical Property Issue; Physical Property Issue

  ANGIODYNAMICS WAS NOTIFIED BY (B)(4), THE SUPPLIER OF INTRODUCER SHEATHS, THAT THEY HAVE INITIATED A RECALL (1649395-05-02-2018-001-R) ON SPECIFIC DEVICE LOTS DUE TO "UNSAFE LEVELS OF BACTERIAL ENDOTOXINS (PYROGENS) THAT WERE INTRODUCED DURING A MANUFACTURING STEP." (B)(4) HAS INFORMED ANGIODYNAMICS THAT USE OF THE INTRODUCERS MAY EXPOSE PATIENTS/END USERS TO "BACTERIAL ENDOTOXINS, ALSO CALLED PYROGENIC BACTERIA THAT CAN ACTIVATE THE INFLAMMATORY PROCESS AND PRODUCE FEVER, CHILLS, AND HYPOTENSION IN A PATIENT." AS A RESULT OF THE (B)(4) RECALL, ANGIODYNAMICS IS CONDUCTING A VOLUNTARY RECALL (REMOVAL) OF THE AFFECTED ANGIODYNAMICS PRODUCTS. THE RECALL NOTIFICATION LETTERS WERE DELIVERED TO AFFECTED CONSIGNEES ON FRIDAY MAY 11, 2018. AFTER RECEIVING NOTIFICATION, THE END USER HOSPITAL HAS REPORTED: "PATIENT EXHIBITED POTENTIAL INFECTIOUS SYMPTOMS THE DAY AFTER PROCEDURE UTILIZING A BIOFLO PICC. INCREASED TEMP AND HR OVER THE FOLLOWING 24 HOURS TO 38.5 (101.3) DESPITE ANTIBIOTICS. BLOOD CULTURES, CHEST X-RAY ID CONSULT ON (B)(6). NO TREATMENT REQUIRED. NO ADDITIONAL MEDICATIONS INITIATED - HAD BEEN ON MORPHINE Q4 IV AND OXYCODONE 4-6 HOURS FOR SEVERAL DAYS. NO CHANGE IN FREQUENCY OF T

  Patient problems: Fever; Unspecified Infection

  MAUDE report 7591595 ↗
• InjuryJun 12, 2018Physical Property Issue; Physical Property Issue

  ANGIODYNAMICS WAS NOTIFIED BY (B)(4), THE SUPPLIER OF INTRODUCER SHEATHS, THAT THEY HAVE INITIATED A RECALL (1649395-05-02-2018-001-R) ON SPECIFIC DEVICE LOTS DUE TO "UNSAFE LEVELS OF BACTERIAL ENDOTOXINS (PYROGENS) THAT WERE INTRODUCED DURING A MANUFACTURING STEP." (B)(4) HAS INFORMED ANGIODYNAMICS THAT USE OF THE INTRODUCERS MAY EXPOSE PATIENTS/END USERS TO "BACTERIAL ENDOTOXINS, ALSO CALLED PYROGENIC BACTERIA THAT CAN ACTIVATE THE INFLAMMATORY PROCESS AND PRODUCE FEVER, CHILLS, AND HYPOTENSION IN A PATIENT." AS A RESULT OF THE (B)(4) RECALL, ANGIODYNAMICS IS CONDUCTING A VOLUNTARY RECALL (REMOVAL) OF THE AFFECTED ANGIODYNAMICS PRODUCTS. THE RECALL NOTIFICATION LETTERS WERE DELIVERED TO AFFECTED CONSIGNEES ON FRIDAY MAY 11, 2018. AFTER RECEIVING NOTIFICATION, THE END USER HOSPITAL HAS REPORTED: "PATIENT EXHIBITED POTENTIAL INFECTIOUS SYMPTOMS THE NEXT DAY. NO TREATMENT REQUIRED. (B)(6) - INCREASED TEMP ONE TIME TO 38.6 (101.5) DESPITE ANTIBIOTICS WITH C/O CHILLS, SWEATS, GENERALIZED ACHES AND HA PATIENT HAD NOW RECALLED PICC LINE DEVICE PLACED (B)(6) 2018.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 7591592 ↗
• MalfunctionMar 20, 2018Fracture; Fracture

  AS REPORTED, AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATION WAS REPORTED. THE USED PICC WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352057 ↗
• MalfunctionMar 20, 2018Fracture; Fracture

  AS REPORTED, AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATION WAS REPORTED. THE USED PICC WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352055 ↗
• MalfunctionMar 20, 2018Fracture; Fracture

  AS REPORTED, AN INDWELLING PICC WAS REMOVED AND REPLACED DUE TO A CRACKED HUB. NO PATIENT INJURY OR COMPLICATION WAS REPORTED. THE USED PICC WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352054 ↗