NA 106A3 (UDI 00613994686077)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994686077), received between Oct 10, 2017 and Apr 5, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem; Infusion or Flow Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE ELECTRICAL UMBILICAL CABLE AND BALLOON CATHETER WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. SERVICE WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684006 ↗
• InjurySep 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE CONSOLE WAS REBOOTED, THE COAXIAL UMBILICAL CABLE, ELECTRICAL UMBILICAL CABLE, AND "THE CATHETER" WERE REPLACED WITHOUT RESOLUTION. THE COAXIAL UMBILICAL CABLE PORT AND COAXIAL CAP WERE CHECKED WITH NO ISSUES. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. A SERVICE VISIT TOOK PLACE AT A LATER DATE AND THE MKS VALVE AND LOW PRESSURE REGULATOR (LPR) WERE REPLACED TO RESOLVE THE ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596771 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CONSOLE WAS HAVING ISSUES. TESTING WAS PERFORMED AT A LATER DATE. SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE SYSTEM WAS VENTED. THERE WAS A DIP IN FLOW AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL PORT WAS BLOCKED. THE O-RING AND TIP WERE REMOVED, RESOLVING THE ISSUES. THE COAXIAL CAP WAS ALSO BROKEN. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829313 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE CONSOLE WOULD NOT POWER ON. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9734892 ↗
• InjurySep 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE ELECTRICAL UMBILICAL CABLE, COAXIAL UMBILICAL CABLE AND CATHETER WERE REPLACED WITHOUT RESOLVE. THE TANK WAS REPLACED AND SYSTEM WAS VENTED. IT WAS NOTED THERE WAS AIR 'IN THE LINES.' THE TANK WAS REPORTED TO POSSIBLY HAVE ACCUMULATED CONDENSATION. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT WAS RECOMMENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9071855 ↗
• InjuryOct 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE CONSOLE WOULD NOT PASS THE INTEGRITY TEST. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005265 ↗
• InjuryApr 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT BECAME UNSTABLE WITH HYPOTENSION AND BRADYCARDIA. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 7462168 ↗
• InjuryApr 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING A MECHANICAL COMPONENT ERROR. ADDITIONALLY, IT WAS NOTED THAT THE SYSTEM NOTICE WAS RECEIVED MULTIPLE TIMES WHEN REBOOTING THE CONSOLE. THE CONSOLE WAS REBOOTED WITH THE SCAVENGING HOSE DISCONNECTED WITHOUT RESOLVE. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441038 ↗
• InjuryApr 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING A MECHANICAL COMPONENT ERROR. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE IS A PROBLEM WITH THE SYSTEM. IT WAS ALSO REPORTED THAT FLOW AND PRESSURE ISSUES WERE OBSERVED. THE CONSOLE WAS REBOOTED SEVERAL TIMES WITHOUT RESOLVE. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7412331 ↗
• InjuryDec 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLVE. THE TANK WAS REPLACED AND SYSTEM WAS VENTED WITHOUT RESOLVE. ADDITIONALLY, AN UNKNOWN SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE BALLOON WAS NOT SUFFICIENTLY INFLATED. THE COAXIAL UMBILICAL CABLE WAS REPLACED AGAIN WITHOUT RESOLVE, AND THE CONSOLE WAS REBOOTED AGAIN WITHOUT RESOLVE. A FIELD SERVICE VISIT TOOK PLACE ON A LATER DATE, AND THE CONSOLE WAS SERVICED AS APPROPRIATE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2017 ADDITIONAL INFORMATION REPORTED THAT TEST INJECTIONS WERE PERFORMED AND THE INFLATION ISSUE WAS NOT REPRODUCED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7075161 ↗
• InjuryOct 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED MULTIPLE TIMES INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. ALL CABLES AND THE TANK WERE DISCONNECTED AND RECONNECTED WITHOUT RESOLVE. THE COAXIAL UMBILICAL CABLE AND ELECTRICAL UMBILICAL CABLE WERE REPLACED AND THE CONSOLE WAS REBOOTED, ALL WITHOUT RESOLVE. THE TANK WAS THEN REPLACED WITHOUT RESOLVE. THE SYSTEM WAS VENTED AND THE BALLOON CATHETER WAS REPLACED, BOTH WITHOUT RESOLVE. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT ON THE CONSOLE TOOK PLACE ON A LATER DATE. DURING SERVICE, THE MKS VALVE WAS REPLACED, AND THE CONSOLE PASSED FULL INSPECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6936601 ↗

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.