TESIO® CATHETER MCTC1235SDRecalls & reported problems
Medical Components, Inc. · 12F TESIO® CATHETER SET (CUFF 22CM FROM TIP) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908027242), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 death.
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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Cardiac Arrest1
- Hemorrhage/Blood Loss/Bleeding1
- Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT HAD THE DIALYSIS CATHETER SINCE (B)(6) THIS YEAR. LAST WEDNESDAY AUGUST 9TH THE PATIENT WENT FOR DIALYSIS AND WAS CONNECTED TO THE MACHINE FOR 3H50M. 10 MINUTES BEFORE THE END THE CATHETER SORT OF RUPTURED. IT DISCONNECTED ABOVE THE TEGO CONNECTOR. THE PATIENT STARTED BLEEDING AND WENT INTO SHOCK AND NEEDED CPR. UNLUCKILY THE PATIENT DID NOT SURVIVE THIS EVENT.
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Shock
MAUDE report 17555770 ↗
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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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