BioFlo Vortex CT60LPBDVIRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787CT60LPBDVI0), received between Aug 2, 2023 and Aug 22, 2023 — classified as 3 injuries.

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.

• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 2 WEEKS AFTER A 6F LOW PROFILE PLASTIC BIOFLO VORTEX PORT IMPLANTATION, THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF AN INFECTION ALONG THE PORT TRACT AND IN THEIR NECK. THE PATIENT WAS PLACED ON AN ANTIBIOTIC TREATMENT AND SEEMED TO IMPROVE; HOWEVER, ONCE THE ROUND OF ANTIBIOTICS WAS COMPLETED, THE PATIENT DEVELOPED A FEVER. A DIFFERENT ANTIBIOTIC WAS PRESCRIBED AND THE DECISION WAS MADE TO REMOVE THE PORT. CULTURES OF THE PORT POCKET WERE NEGATIVE AND THE PORT HAD NOT YET BEEN USED FOR TREATMENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 17596091 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED AN ISSUE WITH A 6F LOW PROFILE PLASTIC BIOFLO VORTEX PORT. IT WAS REPORTED THAT THE PATIENT BEGAN DEVELOPING SYMPTOMS OF AN INFECTION ON (B)(6) 2023. THE PATIENT WAS SEEN BY THE PHYSICIAN, THE FOLLOWING DAY, AND WAS PRESCRIBED CIPROFLAXCIN WITH ROCEPHIN AFTER CULTURING THE SITE. THE PATIENT'S CULTURE RETURNED WITH POSITIVE RESULTS FOR STAPHYLOCOCCUS AUREUS. AFTER ANTIBIOTIC TREATMENT, CULTURES WERE NEGATIVE; HOWEVER, THE TRACT STILL REMAINED INFLAMED BUT THE PORT POCKET WAS NOT INVOLVED. ULTIMATELY, THE PORT WAS REMOVED AND IT WAS NOTED THAT AT THE TIME OF REMOVAL, PURULENT DRAINAGE WAS COMING FROM THE TRACT. IT WAS REPORTED THAT THE PATIENT IS DOING "OK.".

  Patient problems: Unspecified Infection

  MAUDE report 17442145 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED AN ISSUE WITH A 6F LOW PROFILE PLASTIC BIOFLO VORTEX PORT. IT WAS REPORTED THAT THE PATIENT BEGAN DEVELOPING PUFFINESS AND TENDERNESS ON (B)(6) 2023 AND WENT TO THE EMERGENCY ROOM. THE PATIENT WAS PLACED ON CLINDAMYCIN 300 EVERY 8 HOURS BUT DID NOT TOLERATE IT WELL AND TOOK A DOSE CLOSER TO EVERY 10 HOURS. THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2023 AND WAS CHANGED TO LEVAQUIN AFTER NOTING TENDERNESS AND INDURATION ALONG THE PORT CATHETER SITE, TRACKING TO THE NECK. THE PORT POCKET DOES NOT SEEM TO BE INVOLVED AND THE PATIENT STILL HAS THE PORT IMPLANTED AND IS HOPING TO KEEP IT.

  Patient problems: Unspecified Infection

  MAUDE report 17442144 ↗