NA 106A3 (UDI 00613994775955)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994775955), received between Mar 7, 2017 and Jan 6, 2023 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Protective Measures Problem” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING SET UP FOR A CRYO ABLATION PROCEDURE, THERE WAS A NO INPUT DETECTED NOTICE ON SCREEN WHEN THE CONSOLE WAS POWERED ON. THE CONSOLE WAS MAKING APPROPRIATE NOISE AND THE CONSOLE FUNCTIONED NORMALLY DURING BOOT UP. THE MONITOR CABLE WAS FASTENED SECURELY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114093 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE CASE WAS ABORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420097 ↗
• InjuryJul 11, 2022Appropriate 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 SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE CONSOLE WAS RESTARTED, THE BALLOON CATHETER, ELECTRICAL UMBILICAL CABLE, COAXIAL UMBILICAL CABLE AND AUTO CONNECTION BOX WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. SERVICE WAS PERFORMED AT A LATER DATE.  THE INJECTION PROPORTIONAL VALVE (MKS) AND THE VALVE BOARD WERE REPLACED WHICH RESOLVED THE ISSUE. THE CONSOLE WAS SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977809 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING A MECHANICAL COMPONENT ERROR. A REBOOT WAS PERFORMED AND BOTH THE ELECTRICAL UMBILICAL CABLE AND COAXIAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLUTION. IT WAS ALSO REPORTED THAT AN ERROR WAS RECEIVED INDICATING THAT THE REFRIGERANT LEVEL WAS LOW. A FOOT PEDAL WAS USED AND AFTER COMING ON ABLATION, THE BALLOON CATHETER DEFLATED. SUBSEQUENTLY, THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13293940 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FIELD SERVICE VISIT TOOK PLACE AT A LATER DATE. THE LOW PRESSURE REGULATOR (LPR) GAUGE READING WAS HIGHER THAN EXPECTED. THE SYSTEM WAS VENTED, RESOLVING THE ISSUE. WHEN THE INFLATION BUTTON WAS PRESSED, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE INJECTION PANEL WAS BENT IN SEVERAL PLACES DURING SHIPPING, INCLUDING THE T BAR CONNECTING TO THE BALLOON PANEL/S7 AND THE METAL PIPING AROUND THE LPR GAUGE. AFTER THE INJECTION PANEL WAS REPLACED, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS A PROBLEM WITH THE REFRIGERANT PORT. THE CONNECTIONS WERE CHECKED. A NEW PANEL WAS REPLACED WITHOUT RESOLVING THE ISSUE. A BLOCKAGE WAS NOTED; A SYSTEM FLUSH WAS CONDUCTED AND TUBING WAS REPLACED. THERE WAS A 'SUDDEN BURST' OF PRESSURE OUT OF THE COAX PORT THAT INDICATED MOISTURE HAD BEEN RELIEVED FROM THE SYSTEM. THEN, A LEAK WAS NOTED AT THE COAXIAL PORT CONNECTION FROM CONSOLE TUBING. THE CONNECTION WAS TIGHTENED, BUT THE CONSOLE COULD NOT ABLATE OR INFLATE. THE FLOW WAS CALIBRATED TO RESOLVE THE ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264714 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED PHRENIC NERVE PALSY (PNP). THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PNP RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8749486 ↗
• MalfunctionMay 16, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE RADIOFREQUENCY GENERATOR WAS POWERED OFF, CARTOGRAPHY TEMPORARILY DISCONNECTED, AND THE ELECTRICAL UMBILICAL CABLE, AUTO CONNECTION BOX AND BALLOON CATHETER REPLACED WITHOUT RESOLVE. A SECOND CONSOLE WAS USED AND OUTLETS WERE SWITCHED WITHOUT RESOLVE. THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION. WHEN MAPPING WITH CARTOGRAPHY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE CONSOLE WAS CHECKED AND FOUND TO BE WORKING AS INTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 8617708 ↗
• InjuryNov 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER COULD NOT BE RECOGNIZED BY THE CONSOLE. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITH OUT RESOLVE. THE BALLOON CATHETER WAS THEN REPLACED WITH RESOLVE. HOWEVER, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED AN ELECTRICAL COMPONENT FAILURE ALONG WITH A THERMOCOUPLE ISSUE. THE BALLOON CATHETER WAS THEN REPLACED WITHOUT RESOLVE. THE CASE WAS THEN 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 8061455 ↗
• InjuryOct 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A BASELINE FLOW ICON WAS SEEN AT THE BEGINNING OF A CASE. THE COAXIAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. THE FLOW VALUE WAS OUT OF TOLERANCE. THE ELECTRICAL UMBILICAL CABLE AND COAXIAL UMBILICAL CABLE WERE DISCONNECTED WITHOUT RESOLUTION. THE SYSTEM WAS REBOOTED, AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THEN, THE ELECTRICAL UMBILICAL CABLE WAS DISCONNECTED AND RECONNECTED AGAIN, AND THE SYSTEM NOTICE RESOLVED. THE BASELINE FLOW ICON WAS STILL PRESENT, AND THE FLOW WAS OUT OF TOLERANCE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. A FIELD SERVICE VISIT TOOK PLACE AT A LATER DATE AND THE HIGH BASELINE FLOW WAS RESOLVED WHEN THE FLOW METER WAS ZEROED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8002005 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT LEVEL WAS TOO LOW TO CONTINUE. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE IS A PROBLEM WITH THE SYSTEM. THE TANK WEIGHT WAS NOTED TO BE FLUCTUATING. THE CONSOLE WAS REBOOTED SEVERAL TIMES, AND THE TANK WAS REPLACED WITHOUT RESOLUTION. A FIELD SERVICE VISIT WAS RECOMMENDED. 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 7843534 ↗
• InjuryDec 21, 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 INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE WAS UNPLUGGED WITHOUT RESOLVE. THE COAXIAL CABLE WAS REPLACED AND THE CONSOLE WAS REBOOTED, AND A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE IS A PROBLEM WITH THE SYSTEM. ADDITIONALLY, AN UNKNOWN SYSTEM NOTICE WAS RECEIVED SEVERAL TIMES INDICATING A FAILURE OF THE FLOW CURVE TEST (FCT). A POWER UP TEST WAS THEN MANUALLY STARTED WITHOUT RESOLVE. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE TOOK PLACE ON A LATER DATE, AND THE CONSOLE WAS SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139602 ↗
• InjurySep 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE BALLOON CATHETER WAS REPLACED AND THE CONSOLE REBOOTED, WITHOUT RESOLVE. ADDITIONALLY, LOW PRESSURE REGULATOR (LPR) VALUES WERE NOT AS EXPECTED. ANOTHER INFLATION WAS THEN ATTEMPTED, AND THE BALLOON WAS ABLE TO INFLATE, BUT THEN SUDDENLY DEFLATE. IT WAS ALSO REPORTED THAT THE SYSTEM FLUSH COULD NOT BE INITIATED, AND THE ACCOUNT WAS RUNNING SHORTER INFLATIONS. MOREOVER, THE COAXIAL UMBILICAL CABLE WAS NOTED TO HAVE MOISTURE WITHIN, AND THE COAXIAL CABLE WAS REPLACED WITHOUT RESOLVE. ADDITIONALLY, THE COAXIAL ICON APPEARED ON THE SCREEN AND FLOW VALUE WAS NOT AS EXPECTED. THE COAXIAL CAP WAS REPLACED, AND THE CONSOLE WAS AGAIN REBOOTED WITHOUT RESOLVE. THE CV4 WAS CHECKED, WITH NO RESOLVE. THE CASE WAS ABORTED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT ON THE CONSOLE 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 6897672 ↗
• InjuryJun 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A LEAK IN THE REFRIGERANT HOSE WAS HEARD AND OBSERVED. THE TANK WAS REPLACED MULTIPLE TIMES WITHOUT RESOLVE. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE 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 6619199 ↗
• InjuryMar 7, 2017No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE VACUUM WAS DISABLED DUE TO A PROBLEM WITH THE COAXIAL UMBILICAL CABLE. IT WAS NOTED THAT A ¿SNAP¿ WAS HEARD AND THE CONNECTION BETWEEN THE BALLOON CATHETER AND COAXIAL CABLE WAS FROZEN. THE COAXIAL UMBILICAL CABLE WAS REPLACED. AT THE NEXT FREEZE, THE ¿FLASHING COAXIAL CONNECTION¿ WAS OBSERVED ON THE SCREEN. ADDITIONALLY, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. THE BALLOON CATHETER WAS REPLACED. FLOW ISSUES CONTINUED AND THE COAXIAL UMBILICAL WAS REPLACED AND THE CONSOLE WAS REBOOTED WITHOUT RESOLVE. 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 6384767 ↗

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.