NA 2035UCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20643169352777), received between Feb 15, 2019 and Feb 15, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE PACKAGING OF SIX ELECTRICAL UMBILICAL CABLES WERE EASIER TO OPEN THAN NORMAL AND THE STERILITY OF THE CABLES WAS QUESTIONED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8342616 ↗
• MalfunctionFeb 15, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE PACKAGING OF SIX ELECTRICAL UMBILICAL CABLES WERE EASIER TO OPEN THAN NORMAL AND THE STERILITY OF THE CABLES WAS QUESTIONED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8342613 ↗
• MalfunctionFeb 15, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE PACKAGING OF SIX ELECTRICAL UMBILICAL CABLES WERE EASIER TO OPEN THAN NORMAL AND THE STERILITY OF THE CABLES WAS QUESTIONED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8342610 ↗
• MalfunctionFeb 15, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE PACKAGING OF SIX ELECTRICAL UMBILICAL CABLES WERE EASIER TO OPEN THAN NORMAL AND THE STERILITY OF THE CABLES WAS QUESTIONED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8342607 ↗
• MalfunctionFeb 15, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A CRYOABLATION PROCEDURE, THE PACKAGING OF SIX ELECTRICAL UMBILICAL CABLES WERE EASIER TO OPEN THAN NORMAL AND THE STERILITY OF THE CABLES WAS QUESTIONED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8342605 ↗
• MalfunctionFeb 15, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE PACKAGING OF SIX ELECTRICAL UMBILICAL CABLES WERE EASIER TO OPEN THAN NORMAL AND THE STERILITY OF THE CABLES WAS QUESTIONED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8342598 ↗

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.