BioFlo 60M1303115Recalls & reported problems
Navilyst Medical, Inc. · PICC Convenience Kit · Class 2 · Implant
All models of BioFlo (87)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H96560M13031150), received between Oct 20, 2022 and Oct 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ONE DAY POST PLACEMENT OF A RS TANDEM 5F DL BIOFLO PICC , WITH THE PATIENT HAVING ALREADY RECEIVED A TREATMENT VIA THE PICC, IT WAS FOUND TO BE MISSING THE WHITE CONNECTOR ON THE DOUBLE LUMEN. THE LINE WAS IMMEDIATELY REMOVED, AND A BARD PICC WAS PLACED. THE PATIENT WAS DISCHARGED AFTER 2ND CHEMO TREATMENT VIA THE BARD PICC, AND THE ONCOLOGIST WILL MONITOR FOR INFECTION. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638254 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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