NA 203CX (UDI 00643169950146)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169950146), received between Nov 13, 2017 and Apr 16, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2020Device Alarm System; Deflation Problem; Noise, Audible

  INCIDENT DESCRIPTION: DURING CRYO BALLOON ABLATION, A POP SOUND WAS HEARD WHEN INFLATED BALLOON CAME ON FREZZ (SP?). DEFLATED, REMOVED BALLOON FROM THE PATIENT. OPENED NEW BALLOON ATTACHED TO UMBILICAL CABLE. THE SAME THING HAPPENED, WITH SAME ERROR CODE: 50030, IT SAID "TRY CHANGING UMBILICAL CABLE." WHEN WE DID THIS, NO PROBLEM. WE CONTINUED WITH THE PROCEDURE. THE PATIENT WAS STABLE WHEN THEY LEFT THE PROCEDURE ROOM. THE PROCEDURE WAS COMPLETED WITH THE FOLLOWING FINDINGS: FINDINGS: NORMAL SINUS RHYTHM AT BASELINE WITH NORMAL AH, HV, QRS AND QT INTERVALS WITH POST ABLATION TESTING REVEALING ABSENCE OF DUAL AV NODE PHYSIOLOGY. SUCCESSFUL PULMONARY VEIN ISOLATION USING A CRYO CATH BALLOON OF ALL 4 PULMONARY VEINS FOR PAROXYSMAL ATRIAL FIBRILLATION. SUCCESSFUL RIGHT ATRIAL FLUTTER ABLATION AT THE CAVOTRICUSPID ISTHMUS WITH CREATION OF BIDIRECTIONAL BLOCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9967294 ↗
• MalfunctionMay 17, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, BLACK SPOTS WERE OBSERVED IN THE STERILE PACKAGING OF THE COAXIAL UMBILICAL CABLE. THE PRODUCT WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8621715 ↗
• MalfunctionNov 13, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK SPOTS WERE OBSERVED ON THE COAXIAL UMBILICAL CABLE IN THE UNOPENED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7024010 ↗

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.