N/A 2035URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000279769), received between Jun 26, 2024 and Jun 26, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Protective Measures Problem” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 23, 2021Terminated

   Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

   Z-1564-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE CONSOLE COULD NOT RECOGNIZE THE TWO FOCAL CATHETERS AFTER CONNECTION. THE ELECTRICAL UMBILICAL CABLE, AUTO CONNECTION BOX AND FOCAL CATHETER WERE REPLACED WITHOUT RESOLUTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. AFTER THE CASE, TROUBLE SHOOTING WAS CARRIED OUT. THE CONSOLE RECOGNIZED THE TEST FOCAL CATHETER. BOTH OF THE FOCAL CATHETERS THAT WERE USED IN THE CASE WERE CONNECTED TO THE ELECTRICAL UMBILICAL CABLE, AND THE ISSUE REOCCURRED. A PREVENTATIVE MAINTENANCE WAS LATER CARRIED OUT AND THE LOAD CELL WAS NOT AS EXPECTED. IT WAS NOTED THAT THE ROOM TEMPERATURE WAS COLD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619779 ↗

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 · Terminated
  Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
• Z-1452-06 · Aug 4, 2006 · Terminated
  7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.