BioFlo 60M700936Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H96560M7009360), received between Jul 9, 2025 and May 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Difficult to Flush; Deformation Due to Compressive Stress

  A CANADA DISTRIBUTOR REPORTED AN ISSUE WITH A 5F DL BIOFLO PASV PICC. IT WAS REPORTED THAT A PATIENT EXPERIENCED DISCOMFORT WHEN FLUSHING THE GREY LUMEN PLACED IN THE UPPER ARM, WITH POSITIONAL FLOW NOTED. EVALUATION BY THE IV TEAM FOUND NO MECHANICAL OCCLUSION OR KINKING, INCLUDING REVIEW OF A PRIOR CHEST X-RAY. DURING SIMULTANEOUS FLUSHING OF BOTH LUMENS, BULGING WAS OBSERVED APPROXIMATELY 1 CM FROM THE INSERTION SITE. THE PICC WAS REMOVED AND REPLACED, RESULTING IN ADDITIONAL INTERVENTION AND DELAY IN TREATMENT.

  Patient problems: Discomfort

  MAUDE report 25323575 ↗
• MalfunctionJul 30, 2025Crack; Crack

  A SPECTRUM TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A CAN 5F DL BIOFLO PASV PICC NURSING TRAY. IT WAS REPORTED THAT THERE WAS A CRACK IN THE PICC LINE, AT THE CLEAR TUBING JUST BELOW THE PASV HUB. THE PICC WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666882 ↗
• MalfunctionJul 9, 2025Crack; Crack

  A SPECTRUM TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A CAN 5F DL BIOFLO PASV PICC NURSING TRAY, (B)(6) HOSPITAL (B)(6). ON (B)(6) 2025, IV THERAPY PAGED TO GENERAL SURGERY WARD TO ASSESS A LEAKING DOUBLE LUMEN PICC LINE (INSERTED (B)(6) 2025 AT SPH BY PICC TEAM AT BEDSIDE). WHEN THE IV NURSE SAW THE PATIENT, THE UNIT NURSE HAD ALREADY DISCONNECTED THE LINE AND STOPPED INFUSION (WAS RUNNING 2-IN-1 TPN AND D51/2 NS). THE IV NURSE STATED BLOOD WAS BACKED UP INTO THE EXTENSION LEG AND DIFFICULT TO FLUSH. PATIENT WAS WET FROM TPN AND BLOOD. IV NURSE ATTEMPTED TO FLUSH PURPLE LUMEN, BUT IT FELT FULLY OCCLUDED, NOTICING A "PINHOLE SIZED CRACK" BREACH IN THE CLEAR LEG EXTENSION, JUST BELOW THE PURPLE LUMEN HUB, AS BLOOD DROPLETS WERE VISIBLY COMING OUT FROM THERE. WHEN DOING A FULL ASSESSMENT, THE IV NURSE STATED BLOOD WAS BACKING BACK UP AND OUT OF THE LUMEN AND 'PINHOLE CRACK' WHEN REMOVING THE NEEDLESS CONNECTOR CAP. IV NURSE IMMEDIATELY REMOVED THE PICC LINE AND SECUREACATH, AND THE UNIT NURSE INFORMED MD. A NEW PICC WAS INSERTED THE SAME DAY TO CONTINUE TPN TREATMENT. IV THERAPY CLINICAL RESOURCE NURSE FOLLOWED-UP TO ASSESS THE REMOVED PICC. FLUSHED BOTH L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461853 ↗