Arctic Front Advance Pro™ AFAPRO28 (UDI 00763000431464)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00763000431464), received between Jan 7, 2022 and Jul 26, 2023 — classified as 15 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (14 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER COULD NOT COMPLETELY ADVANCE THROUGH THE BALLOON CATHETER. 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 17401473 ↗
• MalfunctionJun 9, 2023Use of Device Problem; Material Integrity Problem; Material Twisted/Bent; Use of Device Problem; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE RIGHT INFERIOR PULMONARY VEIN HAD RESIDUAL POTENTIALS SO ADDITIONAL FREEZING WAS PERFORMED SEVERAL TIMES BUT THERE WAS DIFFICULTY OCCLUDING. THE BALLOON CATHETER WAS INTENSIFIED AND PULLED AND THEN A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE CASE WAS COMPLETED WITH CRYO WITH RADIOFREQUENCY TOUCH-UPS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098551 ↗
• MalfunctionMay 9, 2023Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem; Material Integrity 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 FLUID IN THE CATHETER AND STOPPED THE INJECTION. 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 16896754 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INTEGRATED NEEDLE/DILATOR COULD NOT FIT INTO THE SHEATH. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. IT WAS FURTHER REPORTED THAT THERE WAS LOSS OF PHRENIC NERVE MOVEMENT DURING FREEZING OF THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). AN IMMEDIATE DOUBLE STOP WAS PERFORMED WITH LOSS OF DIAPHRAGM INNERVATION. THE PROXIMAL SEAL TECHNIQUE WAS PERFORMED PRIOR TO OCCLUSION. THE PATIENT WAS MONITORED FOR TWENTY-FIVE MINUTES FOLLOWING THE ABLATION BUT THE PHRENIC NERVE HAD NOT RECOVERED. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED OVERNIGHT AND SUBJECTED TO A "SNIFF" TEST THAT HAD FAILED. THE PHRENIC NERVE PALSY (PNP) HAD NOT RECOVERED PRIOR TO DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 16844617 ↗
• MalfunctionApr 19, 2023Mechanical Problem; Use of Device Problem; Material Integrity Problem; Material Twisted/Bent; Mechanical Problem; Use of Device Problem; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE APPEARED TO BE AN EXTERNALIZED GUIDE WIRE OR PULL WIRE FROM THE BALLOON CATHETER UNDER FLUOROSCOPY. ADDITIONALLY, THERE WAS DIFFICULTIES ACHIEVING OCCLUSION. 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 16773923 ↗
• MalfunctionApr 4, 2023Material Integrity Problem; Protective Measures Problem; Material Integrity Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AFTER FOUR FREEZES WERE COMPLETED A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE BALLOON CATHETER, COAXIAL UMBILICAL CABLE AND ELECTRICAL UMBILICAL CABLE WERE 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 16675484 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY TO A SUCCESSFUL CRYO ABLATION PROCEDURE, PATIENT NOTED ELEVATED HEART RHYTHM VIA FITNESS AND ACTIVITY TRACKER SMARTWATCH. ANTIARRHYTHMIC MEDICATION WAS PRESCRIBED FOR APPROXIMATELY A MONTH. CARDIOVERSION WAS PERFORMED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Flutter

  MAUDE report 16667485 ↗
• MalfunctionMar 14, 2023Mechanical Problem; Infusion or Flow Problem; Material Deformation; Material Twisted/Bent; Mechanical Problem; Infusion or Flow Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE BALLOON CATHETER INFLATION WAS NOT AS EXPECTED. ON FLUOROSCOPY, IT WAS NOTED THAT THE SHAFT OF THE INNER PORTION OF THE BALLOON WAS BENT. THE BALLOON CATHETER WAS REMOVED AND EXAMINED; THE BALLOON INNER SHAFT WAS KINKED AND HAD A "STRANGE SHAPE." 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. ON (B)(6) 2023 AFTER A COMPLETED CASE, THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537657 ↗
• MalfunctionMar 13, 2023Material Deformation; Material Twisted/Bent; Temperature Problem; Material Deformation; Material Twisted/Bent; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER TUBE WAS KINKED AND TEMPERATURES WERE WARMER THAN EXPECTED. 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 16528819 ↗
• MalfunctionFeb 27, 2023Protective Measures Problem; Protective Measures 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 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 16449291 ↗
• MalfunctionFeb 23, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE TIP OF THE BALLOON CATHETER WAS NOTED TO BE CURVED. 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 16429425 ↗
• MalfunctionFeb 20, 2023Material Twisted/Bent; Device Handling Problem; Material Twisted/Bent; Device Handling Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, UNNATURAL BENDING OF THE BALLOON CATHETER WAS CONFIRMED WHILE IT WAS BEING INFLATED EXTERNALLY. 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 16406375 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, PHRENIC NERVE INJURY (PNI) OCCURRED DURING RIGHT SUPERIOR PULMONARY VEIN (RSPV) ABLATION. IT WAS NOTED BY THE PHYSICIAN THAT AFTER 62 SECONDS THE "PALPITATION OF THE DIAPHRAGM STOPPED." THE PROCEDURE WAS STOPPED IMMEDIATELY, AND THE PNI DID NOT RECOVER BY THE END OF THE PROCEDURE. THE CASE WAS COMPLETED WITH CRYO. IT WAS FURTHER REPORTED THAT THE DAY AFTER THE PROCEDURE AN X-RAY SCAN WAS PERFORMED AND THE PATIENT'S PNI STILL HAD NOT RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 16314956 ↗
• MalfunctionJan 24, 2023Device Contamination with Body Fluid; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem; Device Contamination with Body Fluid; Material Integrity Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHILE THE BALLOON CATHETER WAS IN THE PATIENT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THEN WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED BLOOD IN THE CATHETER HANDLE, THE INJECTION WAS STOPPED AND THE VACUUM DISABLED. BLOOD WAS FOUND BETWEEN THE INNER BALLOON AND OUTER BALLOON, AT THE TIP OF THE BALLOON CATHETER AND INSIDE THE COAXIAL CAP ON THE CONSOLE. THE CASE WAS COMPLETED WITH CRYO. AFTER A SERVICE VISIT TOOK PLACE AND THERE WAS NO ISSUES NOTED WITH THE CONSOLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233784 ↗
• InjuryDec 18, 2022Material Integrity Problem; Protective Measures Problem; Material Integrity Problem; 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 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 16001566 ↗
• MalfunctionDec 16, 2022Use of Device Problem; Material Twisted/Bent; Temperature Problem; Use of Device Problem; Material Twisted/Bent; Temperature Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WERE UNEXPECTED, DRASTIC TEMPERATURE DROPS AND OCCLUSION DIFFICULTIES. DESPITE 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 15997828 ↗
• InjuryDec 6, 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 AND PRIOR TO FREEZING ANY OF THE VEINS, BLOOD WAS NOTICED IN THE ENDOTRACHEAL  (ET) TUBE AND SUCTION WAS PERFORMED. THE LEFT SUPERIOR PULMONARY VEIN (LSPV), LEFT INFERIOR PULMONARY VEIN (LIPV), AND RIGHT INFERIOR PULMONARY VEIN (RIPV) WERE ABLE TO BE FROZEN. DURING THIS TIME, SEVERAL ATTEMPTS AT SUCTIONING THE ET TUBE WERE PERFORMED. THE BLOOD VOLUME IN THE ET TUBE INCREASED AND THE PATIENT'S BLOOD OXYGEN SATURATION BEGAN TO DECREASE. BLOOD HAD POOLED INTO THE PATIENT'S LEFT LOWER LUNG LOBE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS HOSPITALIZED AS A RESULT OF THE EVENT BUT HAS BEEN EXTUBATED AND IS STABLE. THE PHYSICIAN BELIEVES THAT THE INJURY INITIALLY OCCURRED DURING INTUBATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoxia; Pulmonary Embolism

  MAUDE report 15927346 ↗
• MalfunctionNov 30, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A KINK INSIDE OF THE BALLOON WAS OBSERVED DURING AN INFLATION. THE BALLOON CATHETER WAS REPLACED AND THERE WAS A KINK INSIDE OF THE NEW BALLOON. THE BALLOON CATHETER WAS REPLACED AGAIN WHICH RESOLVED THE ISSUE. A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE 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 15891234 ↗
• MalfunctionNov 30, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A KINK INSIDE OF THE BALLOON WAS OBSERVED DURING AN INFLATION. THE BALLOON CATHETER WAS REPLACED AND THERE WAS A KINK INSIDE OF THE NEW BALLOON. THE BALLOON CATHETER WAS REPLACED AGAIN WHICH RESOLVED THE ISSUE. A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE REFRIGERANT DELIVERY PATH WAS OBSTRUCTED. THE COAXIAL UMBILICAL CABLE 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 15891195 ↗
• InjuryNov 28, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT SUFFERED FROM AN ATRIOESOPHAGEAL FISTULA (AEF) AT THE LEFT INFERIOR PULMONARY VEIN (LIPV). THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL REPAIR OF THE FISTULA AND WAS SUBJECTED TO PROLONGED HOSPITALIZATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Air Embolism; Chest Pain; Fistula

  MAUDE report 15869364 ↗
• InjuryOct 21, 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, THERE WAS AN ABRUPT LOSS OF PHRENIC NERVE STIMULATION DURING THE FIRST ABLATION OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV). A DOUBLE STOP WAS PERFORMED AND PACING WAS CONTINUED FOR FIFTY MINUTES WITHOUT RECOVERY. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE DIAPHRAGM WAS ELEVATED. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Nerve Damage

  MAUDE report 15653754 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Protective Measures Problem; Mechanical Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AND UNKNOWN SYSTEM NOTICE WAS RECEIVED. WHILE EXCHANGING BALLOON CATHETERS, A TEAR WAS OBSERVED IN THE BALLOON LEAVING THE PATIENT'S BODY. WHEN THE SECOND BALLOON WAS BEING USED, AN UNKNOWN SYSTEM NOTICE WAS RECEIVED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT'S BODY AND WAS ALSO OBSERVED TO BE TORN. THE TIP OF THE SHEATH WAS THEN DISCOVERED TO BE SHEERED AND SPLINTERED CAUSING IT TO HAVE A SHARP EDGE. THE SHEATH WAS THEN 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 15351067 ↗
• MalfunctionSep 2, 2022Mechanical Problem; Protective Measures Problem; Mechanical Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AND UNKNOWN SYSTEM NOTICE WAS RECEIVED. WHILE EXCHANGING BALLOON CATHETERS, A TEAR WAS OBSERVED IN THE BALLOON LEAVING THE PATIENT'S BODY. WHEN THE SECOND BALLOON WAS BEING USED, AN UNKNOWN SYSTEM NOTICE WAS RECEIVED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT'S BODY AND WAS ALSO OBSERVED TO BE TORN. THE TIP OF THE SHEATH WAS THEN DISCOVERED TO BE SHEERED AND SPLINTERED CAUSING IT TO HAVE A SHARP EDGE. THE SHEATH WAS THEN 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 15350644 ↗
• MalfunctionAug 24, 2022Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS SEEN TRAVELING FROM THE BALLOON CATHETER INTO THE COAXIAL UMBILICAL CABLE DURING ASPIRATION OF THE SHEATH. THE COAXIAL UMBILICAL CABLE WAS DISCONNECTED AND AT THE SAME TIME, AN UNKNOWN SYSTEM NOTICE WAS RECEIVED INDICATING THAT THERE WAS BLOOD DETECTED IN THE CATHETER HANDLE. 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 15282307 ↗
• InjuryAug 16, 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, THE PROCEDURE WAS ABORTED DUE TO ANATOMICAL CHALLENGES. 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 15237063 ↗

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