BIO-FLEX®TESIO®CATHETER CMD755Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884908005530), received between Mar 13, 2018 and Dec 9, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 18, 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.

• InjuryDec 9, 2019Break; Break

  DURING THE INSERTION PROCEDURE, THE SHEATH TUBING SEPARATED FROM THE HUB.

  Patient problems: Device Embedded In Tissue or Plaque; Respiratory Distress

  MAUDE report 9439958 ↗
• MalfunctionMar 13, 2018Connection Problem; Connection Problem

  SCREW THREAD FOR CAP OR DIALYSIS TUBE DOES NOT FIT; INNER DIAMETER OF THE CONE INTO WHICH THE SYRINGE IS, E.G. USED FOR BLOCKING, IS TOO BIG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7333871 ↗
• MalfunctionMar 13, 2018Connection Problem; Connection Problem

  THE BLOOD LINE CANNOT BE CONNECTED WITH THE LUER ADAPTOR (OR WITH MASSIVE MUSCLE POWER ONLY).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7333801 ↗