NA 2035URecalls & reported problems
Medtronic, Inc. · CABLE 2035U ELECTRICAL UMBILICAL BMED · Class 3
- 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 00763000359355), received between Nov 18, 2025 and Nov 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
2 other recalls cover devices cleared under the same FDA submission (P020045); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
- Protective Measures Problem1
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.
MalfunctionNov 18, 2025Off-Label Use; Protective Measures Problem; Off-Label Use; Protective Measures Problem
IT WAS REPORTED THAT WHEN THE ELECTRICAL CABLE FOR THE CARDIAC ABLATION CATHETER WAS CONNECTED, THE SYSTEM DID NOT RECOGNIZE THE CATHETER AND A SYSTEM NOTICE APPEARED INDICATING AN UNRECOGNIZED CATHETER. ATTEMPTS TO DISCONNECT AND RECONNECT THE CABLE DID NOT RESOLVE THE ISSUE, SO THE ELECTRICAL CABLE WAS REPLACED, WHICH RESOLVED THE PROBLEM. THE CASE WAS COMPLETED WITH CRYO. IT WAS LATER NOTED THAT THE ELECTRICAL UMBILICAL CABLE WAS USED PAST ITS USE BY DATE AND WAS EXPIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23579697 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P020045. One submission often covers many models, so check the product and lot details in each record.
- Z-2777-2015 · Sep 1, 2015 · TerminatedMedtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
- Z-1452-06 · Aug 4, 2006 · Terminated7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.