Bio-Flex® Tesio® Catheters BFR1070KD-ARecalls & reported problems
Medical Components, Inc. · 10F X 70CM Bio-Flex® Tesio® CATHETER KIT (ARTERIAL CUFF - 46CM FROM TIP)(VENOUS CUFF - 50CM FROM TIP) · Class 2 · Implant
Data updated Oct 18, 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 00884908004977), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Hematoma1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2021Leak/Splash; Leak/Splash
CATHETER WAS PLACED IN THE LEFT FEMORAL VEIN. PATIENT STARTED TO HAVE BURNING SENSATION IN GROIN AREA, ON THE SAME DAY LOCAL HEMATOMA APPEARED. PATIENT WENT TO OPERATING ROOM, AND ON CTC SCAN WITH CONTRAST IT WAS SEEN 2 RUPTURES ON CATHETER. FIRST RUPTURE WAS IN THE TUNNEL, AND SECOND RUPTURE WAS AT THE CONNECTION OF CUFF AND CATHETER.
Patient problems: Hematoma; Pain
MAUDE report 13022219 ↗
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- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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