Arctic Front Advance™ 2AF284 (UDI 00763000431532)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00763000431532), received between Jan 16, 2024 and Mar 25, 2025 — classified as 8 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (9 reports).

1 other recall cover devices cleared under the same FDA submission (P100010); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE INVOLVING BOTH CRYOABLATION AND RADIOFREQUENCY, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) ARREST. INITIALLY, THE PULMONARY VEINS WERE ABLATED USING CRYOABLATION. IT WAS NOTED THE PATIENT'S OXYGEN SATURATIONS HAD DROPPED DURING THE LAST FREEZE. THE PATIENT THEN HAD RADIOFREQUENCY WITH ANOTHER MANUFACTURER'S CATHETER TO ABLATE THE POSTERIOR WALL. PATIENT THEN EXPERIENCED AN EXTREMELY LOW RHYTHM WHICH PROGRESSED TO VENTRICULAR FIBRILLATION. RESUSCITATION MEASURES, WHICH INCLUDED CARDIOPULMONARY RESUSCITATION (CPR) AND EXTERNAL SHOCKS WERE CARRIED OUT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. IT WAS FURTHER NOTED PATIENT HAD SUSTAINED FRACTURED RIBS, POSSIBLY RELATED TO THE CHEST COMPRESSIONS. THE PROCEDURE WAS COMPLETED USING BOTH CRYO AND RADIOFREQUENCY WITH ANOTHER MANUFACTURER'S CATHETER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bone Fracture(s); Bradycardia; Low Oxygen Saturation; Ventricular Fibrillation

  MAUDE report 21692103 ↗
• MalfunctionJan 29, 2025Compatibility Problem; Infusion or Flow Problem; Material Twisted/Bent; Compatibility Problem; Infusion or Flow Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A MAPPING CATHETER AND A BALLOON CATHETER, THE MAPPING CATHETER WAS UNABLE TO BE MANIPULATED INSIDE THE BALLOON CATHETER, AND IT COULD NOT MOVE FORWARD OR BACKWARD, LEADING TO PHYSICAL DAMAGE. THERE WERE ALSO ISSUES INSERTING THE MAPPING CATHETER INTO THE BALLOON CATHETER. ADDITIONALLY, THE BALLOON CATHETER EXPERIENCED GENERAL EARLY DEFLATION AND PRESSURE/FLOW ISSUES. THE MAPPING CATHETER AND BALLOON CATHETER WERE BOTH REPLACED TO RESOLVE THESE ISSUES. THE PROCEDURE WAS COMPLETED WITH CRYO. IT WAS NOTED THAT IT WAS HARD TO MANIPULATE THE MAPPING CATHETER AND IT WAS BELIEVED THAT THE MAPPING CATHETER WAS KINKED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267083 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION PRIOR TO THE INSERTION OF THE SHEATH. THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. BASELINE IMAGING WAS OBTAINED TO ASSESS FOR PERICARDIAL EFFUSION PRIOR TO THE PROCEDURE. A PERICARDIOCENTESIS WAS PERFORMED TO ADDRESS THE EFFUSION AND TAMPONADE, WHICH RESULTED IN SYMPTOM RESOLUTION PRIOR TO LEAVING THE LAB. THE CASE WAS ULTIMATELY ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20891813 ↗
• MalfunctionDec 6, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE NOT AS EXPECTED. THE BALLOON CATHETER AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. AFTER THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, THERE WAS DIFFICULTY PURGING AIR FROM THE SHEATH. THE BALLOON CATHETER WAS REPLACED BUT THE ISSUE REMAINED. THE BALLOON CATHETER WAS REPLACED A THIRD TIME TO RESOLVE THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869563 ↗
• MalfunctionNov 6, 2024Use of Device Problem; Excessive Cooling; Use of Device Problem; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE COLDER FASTER THAN EXPECTED AND THE VEIN COULD NOT BE ISOLATED. SEVERAL FREEZES WERE CARRIED OUT AND THE ISSUE DID NOT RESOLVE. IMAGING CONFIRMED THE BALLOON CATHETER WAS NOT TOO DEEP IN THE VEIN. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. AFTER THE CASE, TEST FREEZES WERE CARRIED OUT WITH THE BALLOON CATHETER. TEMPERATURE ISSUES AND ICE FORMATION WERE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620627 ↗
• MalfunctionOct 22, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, TEMPERATURES WERE COLDER THAN EXPECTED AT THIRTY SECONDS, RESULTING IN INTERRUPTED ABLATIONS. THE ELECTRICAL UMBILICAL CABLE WAS REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER AND COAXIAL UMBILICAL CABLE WERE REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507972 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, DURING THE FIRST FREEZE OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) THE PHRENIC NERVE STOPPED AT STOPPED AT APPROXIMATELY EIGHTY SECONDS INTO THE FREEZE. THE FREEZE WAS STOPPED AND THE BALLOON CATHETER DEFLATED. THE PHRENIC NERVE DID NOT RECOVER AFTER THIRTY MINUTES. THE CASE WAS ABORTED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AND KEPT OVERNIGHT FOR MONITORING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 20366742 ↗
• MalfunctionOct 3, 2024Material Twisted/Bent; Material Twisted/Bent

  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 BALLOON CATHETER WAS REPLACED WHICH DID NOT RESOLVED THE ISSUE. THE CONSOLE WAS REPLACED WITH THE BACK-UP CONSOLE WHICH RESOLVED THE ISSUE. THE REPLACEMENT BALLOON CATHETER WAS USED WITH THE BACK-UP CONSOLE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357986 ↗
• MalfunctionSep 27, 2024Use of Device Problem; Material Twisted/Bent; Insufficient Device Problem Information; Use of Device Problem; Material Twisted/Bent; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PULMONARY VEINS (PV) COULD NOT BE ISOLATED. TEMPERATURE AND FLOW WERE AS EXPECTED. THE BALLOON CATHETER WAS REMOVED AND TESTED IN A BOWL OF SALINE AND IT WAS NOTED THAT PART OF THE BALLOON CATHETER DEMONSTRATED NO ICE COVERAGE IN THE SALINE. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318026 ↗
• MalfunctionSep 3, 2024Material Twisted/Bent; Protective Measures Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131267 ↗
• MalfunctionAug 21, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE TEMPERATURES DECREASED MORE QUICKLY AND TO LOWER TEMPERATURES THAN EXPECTED. THE CASE WAS SWITCHED TO AND COMPLETED WITH RADIOFREQUENCY. THE DATA FILES WERE LATER REVIEWED AND THE TEMPERATURE ISSUES WERE OBSERVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015537 ↗
• MalfunctionJul 23, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR BUBBLES WERE OBSERVED UPON ADVANCEMENT OF THE BALLOON CATHETER INTO THE SHEATH SIDEPORT. THE BALLOON CATHETER WAS REMOVED AND RE-PREPPED, AND THE SHEATH WAS ASPIRATED AND FLUSHED WITHOUT RESOLUTION. THE ENTIRE SYSTEM WAS RE-PREPPED AGAIN WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810805 ↗
• MalfunctionJul 22, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AIR INGRESS WAS NOTED. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790862 ↗
• MalfunctionJul 2, 2024Device Contamination with Body Fluid; Protective Measures Problem; Device Contamination with Body Fluid; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. THE CASE CONTINUED AND THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DETECTED A SOFTWARE ERROR AND STOPPED THE INJECTION. IT WAS ALSO REPORTED THAT THERE WAS BLOOD IN THE CONNECTION BETWEEN THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER. THE BALLOON CATHETER AND COAXIAL UMBILICAL CABLE WERE REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657515 ↗
• MalfunctionJul 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, BUBBLES WERE NOTED IN THE SHEATH SIDEPORT. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT AND REPREPARED. THE SHEATH WAS THEN ASPIRATED AND FLUSHED WITH SALINE. THE BALLOON CATHETER WAS REINSERTED AND NO BUBBLES WERE VISABLE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642643 ↗
• MalfunctionJun 28, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE UPON INSERTION OF THE BALLOON CATHETER INTO THE SHEATH, AIR BUBBLES WERE OBSERVED IN THE EXTENSION TUBING. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19636306 ↗
• MalfunctionJun 25, 2024Gas/Air Leak; Compatibility Problem; Gas/Air Leak; Compatibility Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS RESISTANCE WHEN INSERTING THE BALLOON CATHETER INTO THE SHEATH. WHEN THE BALLOON CATHETER WAS HALFWAY THROUGH THE SHEATH, AN ATTEMPT WAS MADE TO ASPIRATE BLOOD THROUGH THE SIDE ARM. WHEN THE STOPCOCK WAS OPENED, IT WAS READILY APPARENT THAT THERE WAS A VACUUM PRESENT. AIR INGRESS WAS THEN NOTED. THE BALLOON CATHETER WAS REMOVED RE-PREPPED AND RE-INSERTED WITHOUT RESOLVE. THE BALLOON CATHETER WAS THEN REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604629 ↗
• MalfunctionJun 24, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN THE BALLOON CATHETER WAS INSERTED INTO THE SHEATH, AIR BUBBLES WERE OBSERVED IN THE SIDE PORT OF THE SHEATH. THE BALLOON CATHETER WAS PREPPED AGAIN WITHOUT RESOLUTION. THE SHEATH, MANIFOLD, AND TUBING WERE REPLACED WITHOUT RESOLUTION. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594344 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE DURING THE SECOND FREEZE IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), PHRENIC CAPTURE WAS LOST. THE FREEZE WAS IMMEDIATELY STOPPED. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. THE PHRENIC NERVE WAS NOT CAPTURED AT THE END OF THE CASE. IT IS UNKNOWN IF THE PHRENIC NERVE INJURY RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 19390732 ↗
• MalfunctionMay 21, 2024Gas/Air Leak; Compatibility Problem; Gas/Air Leak; Compatibility Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, IT WAS MORE DIFFICULT THAN USUAL TO INSERT THE BALLOON CATHETER INTO THE SHEATH. IT WAS ALSO REPORTED THAT WHEN ASPIRATING, AIR INGRESS WAS OBSERVED. ADDITIONAL ASPIRATION MANEUVERS WERE PERFORMED; HOWEVER, MULTIPLE AIR BUBBLES WERE STILL PRESENT. THE BALLOON CATHETER AND SHEATH WERE REPLACED WHICH RESOLVED THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360981 ↗
• MalfunctionMay 21, 2024Device Contamination with Body Fluid; Protective Measures Problem; Device Contamination with Body Fluid; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, AN ERROR MESSAGE WAS RECEIVED INDICATING THAT THERE WAS BLOOD DETECTED AT THE CATHETER HANDLE. IT WAS THEN NOTED THAT AFTER THE SYSTEM FLUSH BLOOD WAS SEEN COMING DOWN THE COAXIAL UMBILICAL CABLE LINE. THE SYSTEM NOTICE WAS SILENCED AND THE COAXIAL UMBILICAL CABLE WAS REMOVED TO PROTECT THE CONSOLE. THE BALLOON CATHETER WAS THEN REMOVED AND REPLACED TOGETHER WITH THE COAXIAL UMBILICAL CABLE TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. DATA FILES WERE REVIEWED AND THE SYSTEM NOTICE WAS CONFIRMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358369 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHILE ABLATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), THERE WAS WEAK PHRENIC NERVE CAPTURE. PHRENIC NERVE PALPATION WAS THEN LOST AND A DOUBLE STOP WAS PERFORMED. THE BALLOON CATHETER WAS REPOSITIONED SEVERAL TIMES BUT PHRENIC NERVE WAS UNABLE TO BE CAPTURED. AFTER A WAITING PERIOD, PHRENIC NERVE STIMULATION WAS UNSUCCESSFUL AND THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED. TWO DAYS POST PROCEDURE, A TEST USING CHEST FLUOROSCOPY WAS PERFORMED AND SHOWED RIGHT HEMIDIAPHRAGM PARALYSIS. IT WAS ALSO REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 19355191 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  INCOMING INFORMATION RECEIVED INDICATED THAT UPON INSERTING THE BALLOON CATHETER INTO THE SHEATH JUST PASS THE VALVE, FLUID WAS DRAWN BACK TO CHECK FOR ANY AIR IN THE SHEATH AND ON TWO SHEATHS, AIR WAS OBSERVED IN THE SHEATHS THEMSELVES AND NOT THE BALLOON CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299982 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  INCOMING INFORMATION RECEIVED INDICATED THAT UPON INSERTING THE BALLOON CATHETER INTO THE SHEATH JUST PASS THE VALVE, FLUID WAS DRAWN BACK TO CHECK FOR ANY AIR IN THE SHEATH AND ON TWO SHEATHS, AIR WAS OBSERVED IN THE SHEATHS THEMSELVES AND NOT THE BALLOON CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299756 ↗
• MalfunctionMay 9, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, INFLATION ISSUES OCCURRED AND THREE SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE BALLOON CATHETER WAS REPLACED, BUT THE ISSUE PERSISTED. LOW PRESSURE REGULATOR (LPR) VALUES WERE AS EXPECTED. IT WAS NOTES THAT NO BLOOD HAD REACHED THE CONSOLE. THE CONSOLE WAS SWITCHED OUT FOR ANOTHER. THE CASE OUTCOME IS UNKNOWN. A SERVICE WAS RECOMMENDED AND CARRIED OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280586 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100010. One submission often covers many models, so check the product and lot details in each record.

• Z-0149-2012 · Aug 29, 2011 · Terminated
  Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtr