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BioFlo 60M780126Recalls & 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
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H96560M7801260), received between May 24, 2018 and May 24, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 16, 2026.

Most reported problems

Device problems

  • Obstruction of Flow3
  • Malposition of Device2
  • Kinked1

Patient problems

  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

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

  • MalfunctionMay 24, 2018Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

    AS REPORTED BY HOSPITAL IN (B)(6): PICC PLACED (B)(6) - HD ETOPOSIDE GIVE (B)(6). XRAY ORDERED BY PHYSICIAN FOR IMPROPERLY FUNCTIONING PICC (B)(6) - SEEN COILED IN SVC - COULD NOT BE FLUSHED. WAS REMOVED AND REPLACED (B)(6) - LINE NOTED TO BE DISCOLORED. HOSPITAL HAS STATED THAT THE DFU FOR ETOPOSIDE LISTS POLYURETHANE AS CONTRAINDICATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7540994 ↗
  • MalfunctionMay 24, 2018Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

    AS REPORTED BY HOSPITAL IN (B)(6): PICC PLACED (B)(6) 2018 - SEEN FOR OCCLUSIONS (B)(6) (TPA). INCIDENTAL XRAY (B)(6) SHOWS GOOD POSITIONING. HD ETOPOSIDE GIVEN (B)(6). INCIDENTAL XRAY DONE (B)(6) SHOWS CURL. PICC REMOVED AND REPLACED (B)(6). HOSPITAL HAS STATED THAT THE DFU FOR ETOPOSIDE LISTS POLYURETHANE AS CONTRAINDICATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7540993 ↗
  • MalfunctionMay 24, 2018Kinked; Obstruction of Flow; Kinked; Obstruction of Flow

    AS REPORTED BY HOSPITAL IN (B)(6): PICC PLACED (B)(6) 2018. HD ETOPOSIDE GIVEN (B)(6) AND (B)(6). INCIDENTAL XRAYS DONE (B)(6) SHOW PROPER LINE PLACEMENT. XRAY ORDERED BY PHYSICIAN (B)(6) FOR "POOR FLOW". LINE NOTED TO BE "KINKED IN SVC". PICC WAS REMOVED FOR NEW INSERTION AND LINE DISCOLORATION NOTED. HOSPITAL HAS STATED THAT THE DFU FOR ETOPOSIDE LISTS POLYURETHANE AS CONTRAINDICATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7540992 ↗

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Sources and updates

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