Arctic Front Advance Pro™ AFAPRO28 (UDI 00763000245436)Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00763000245436), received between Feb 5, 2020 and Feb 18, 2022 — classified as 2 deaths, 42 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (33 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 97 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 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, PHRENIC NERVE CAPTURE WAS LOST WHILE PACING ON THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE PATIENT'S PHRENIC NERVE PALSY WAS NOT RECOVERED, AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED OVERNIGHT. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 13563445 ↗
• MalfunctionJan 28, 2022Material Integrity Problem; Material Integrity Problem

  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 13385769 ↗
• MalfunctionJan 12, 2022Material Twisted/Bent; Material Twisted/Bent

  AFTER A COMPLETED CASE, THE BALLOON CATHETER SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURERS INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237435 ↗
• MalfunctionDec 29, 2021Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  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 13110126 ↗
• InjuryDec 20, 2021Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  INCOMING INFORMATION WAS RECEIVED AND INDICATED THAT THE LEFT PULMONARY VEINS (PV) WERE ISOLATED AND WHILE ATTEMPTING TO ISOLATE THE RIGHT INFERIOR PULMONARY VEIN (PV), THE SYSTEM NOTICE WAS RECEIVED FOLLOWED BY THE PATIENT GOING HYPOTENSIVE. THE PATIENT DEVOLVED INTO PULSELESS VENTRICULAR TACHYCARDIA (VT) THEN VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS DEFIBRILLATED MULTIPLE TIMES, CARDIOPULMONARY RESUSCITATION WAS INITIATED, FLUIDS WERE ADMINISTERED DURING RESUSCITATION, AND ANTIARRHYTHMIC MEDICATIONS WERE GIVEN. AFTER THE RETURN OF SPONTANEOUS CIRCULATION, THE PATIENT WAS IN SINUS RHYTHM AND HAD NO OBVIOUS ST ELEVATION BUT SINCE IT WAS UNCLEAR WHAT CAUSED THE DECOMPOSITION, A CARDIAC CATHETERIZATION AND ANGIOGRAM WAS PERFORMED AND REVEALED NORMAL CORONARY ARTERIES AND MILDLY ELEVATED PULMONARY WEDGE PRESSURE CONSISTENT WITH RESUSCITATION. IT WAS SUSPECTED THAT A RUPTURE TO THE BALLOON OCCURRED AND CAUSED LEAK OF NITRIC OXIDE INTO THE HEART. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED GOOD CARDIAC FUNCTION AND NO AIR IN THE CHAMBERS. PINK FROTHY SPUTUM WAS OBSERVED IN THE ENDOTRACHEAL TUBE AND BILATERAL CRACKLES WERE HEARD IN THE LUNGS. A DIURETIC MEDICATION WAS GIVEN FOR P

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrial Fibrillation; Atrial Flutter; Balance Problems; Bone Fracture(s); Bradycardia; Brain Injury; Cardiac Arrest; Cardiac Enzyme Elevation; Chest Pain; Dizziness; Dyspnea; Ectopic Heartbeat; Electrolyte Imbalance; Fatigue; High Pulmonary Arterial Wedge Pressure; Low Blood Pressure/ Hypotension; Memory Loss/Impairment; Pulmonary Edema; Sexual Dysfunction; Tachycardia; Ventilator Dependent; Ventricular Fibrillation

  MAUDE report 13043825 ↗
• MalfunctionNov 22, 2021Inflation Problem; Compatibility Problem; Material Integrity Problem; Material Twisted/Bent; Inflation Problem; Compatibility Problem; Material Integrity Problem; Material Twisted/Bent

  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 12857221 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE WHEN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND THE LEFT COMMON PULMONARY VEIN (LCPV) WERE ABLATED, THE ESOPHAGEAL TEMPERATURE DROPPED RAPIDLY. THE PHYSICIAN ATTEMPTED TO CANNULATE THE RIGHT SIDED VEINS. THE PHYSICIAN RETURNED TO THE LEFT SIDED VEINS AND ATTEMPTED TWO MORE ABLATIONS WHERE THE BALLOON WAS INFLATED AND DEFLATED. AN EFFUSION WAS NOTED. THE PATIENT'S BLOOD PRESSURE STARTED TO DECLINE. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT THE PATIENT WAS SMALL AND HAD A DIFFICULT ANATOMY. PER THE PHYSICIAN, THE EFFUSION LIKELY OCCURRED DURING THE CANNULATION ATTEMPTS OF THE RIGHT SIDED VEINS. IT WAS VISUALIZED ON FLUOROSCOPY AND ON A NON-MEDTRONIC MAPPING SYSTEM, THAT THE PHYSICIAN LED WITH THE MAPPING CATHETER THE ENTIRE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 12832463 ↗
• InjuryNov 15, 2021Adverse 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 LEFT ATRIAL APPENDAGE WAS PERFORATED. PRIOR TO REMOVING THE BALLOON CATHETER FROM THE LEFT ATRIUM, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS LOW. PERICARDIAL EFFUSION WAS IDENTIFIED ON THE ECHOCARDIOGRAM. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TRANSPORTED TO THE OPERATION ROOM FOR SURGERY TO REPAIR THE LEFT ATRIAL APPENDAGE. THE SURGERY WAS SUCCESSFUL. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 12814491 ↗
• DeathNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE WEEKS POST-OPERATIVELY TO A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SYMPTOMS OF SEPSIS. AN ATRIO-ESOPHAGEAL FISTULA WAS DISCOVERED AND SURGICAL INTERVENTION TOOK PLACE IN AN ATTEMPT TO REPAIR IT. THE PATIENT ALSO HAD A "NEUROLOGICAL EVENT" SHORTLY AFTER HOSPITAL ADMISSION. THE PATIENT WAS HOSPITALIZED FOR AN EXTENDED PERIOD OF TIME. TWO WEEKS AFTER THE INITIAL SEPSIS AND FISTULA ONSET, THE PATIENT PASSED AWAY.

  Patient problems: Fistula; Sepsis; Stroke/CVA

  MAUDE report 12783123 ↗
• InjuryNov 7, 2021Adverse 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 THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. 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 12760781 ↗
• DeathOct 26, 2021Adverse 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'S BLOOD PRESSURE WAS FLUCTUATING THROUGHOUT THE CASE. WHILE CANNULATING THE RIGHT INFERIOR PULMONARY VEIN (RIPV), THE BLOOD PRESSURE DROPPED SIGNIFICANTLY. ANESTHESIA WAS USED TO REGULATE THE BLOOD PRESSURE. THE CASE WAS COMPLETED WITH CRYO. THE PATIENT WAS CHECKED FOR AN EFFUSION AND TAMPONADE MULTIPLE TIMES THROUGHOUT THE CASE AND IMMEDIATELY AFTER, THOUGH NONE WAS DETECTED. BLOOD WAS THEN SEEN COMING OUT OF THE INTUBATION TUBE AND A CODE WAS CALLED. A THORACOTOMY WAS PERFORMED TO INVESTIGATE FOR PERFORATIONS BUT IT WAS INCONCLUSIVE. THE PATIENTS CHEST WAS CLOSED AND AN INTERVENTIONAL RADIOLOGIST WAS CALLED TO LOOK FOR A BRONCHIAL OR LUNG PERFORATION, AND AGAIN NOTHING WAS FOUND. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED FOR NEARLY AN HOUR TO NO AVAIL. IT WAS CONCLUDED THE BALLOON CATHETER OR MAPPING CATHETER LIKELY CAUSED A SMALL PERFORATION THAT LED TO INTERNAL BLEEDING IN THE PLEURAL SPACE. THE PATIENT IS DECEASED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 12700786 ↗
• MalfunctionOct 22, 2021Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS SEEN IN THE BALLOON CATHETER HANDLE AND THE DISTAL PORTION OF THE COAXIAL UMBILICAL CABLE. 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 12681932 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, LOSS OF MOVEMENT WAS SEEN IN THE RIGHT DIAPHRAGM DURING ABLATION INDICATING PHRENIC NERVE PALSY (PNP) OCCURRED. A DOUBLE-STOP OF THE CONSOLE WAS PERFORMED AND THE BALLOON CATHETER DEFLATED TO WAIT FOR A RECOVERY. THE PNP DID NOT RESOLVE AFTER THIRTY MINUTES AND 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: Nerve Damage

  MAUDE report 12674723 ↗
• InjuryOct 21, 2021Adverse 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 APPEARED TO BE AN INTERMITTENT CAPTURE OF THE DIAPHRAGM DURING PACING. THE DIAPHRAGMATIC STIMULATION WAS COMPLETELY LOST AND THE ABLATION WAS TERMINATED AND THE BALLOON CATHETER WAS DEFLATED. THE PACING CATHETER WAS ADJUSTED TO VARIOUS POSITION IN THE SUPERIOR VENA CAVA BUT THE DIAPHRAGM WAS STILL NOT CAPTURED. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND IT WAS CONFIRMED NO PARALYTIC AGENT HAD BEEN GIVEN BUT A REVERSAL AGENT WAS GIVEN ANYWAYS. THE PHRENIC NERVE COULD NOT BE CAPTURED. THE CASE WAS SWITCHED TO RADIOFREQUENCY AND WAS COMPLETED WITH RADIOFREQUENCY. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 12673823 ↗
• InjuryOct 7, 2021Adverse 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 PERFORATION OCCURRED AT THE LEFT SUPERIOR PULMONARY VEIN (LSPV). THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS TAKEN TO SURGERY TO CORRECT THE PERFORATION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Great Vessel Perforation

  MAUDE report 12590924 ↗
• MalfunctionSep 27, 2021Device Contamination with Body Fluid; Material Integrity Problem; Device Contamination with Body Fluid; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS OBSERVED ADVANCING INTO THE COAXIAL UMBILICAL CABLE. THE COAXIAL UMBILICAL CABLE WAS UNPLUGGED FROM THE CONSOLE. 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 12538307 ↗
• InjurySep 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PHRENIC PACING WENT AWAY INDICATING PHRENIC NERVE PALSY (PNP). A DOUBLE STOP WAS PERFORMED AND ABLATIONS WERE PAUSED FOR 20 MINUTES WHEN THE PATIENT FULLY RECOVERED. 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 12506378 ↗
• MalfunctionSep 20, 2021Material Integrity Problem; Material Integrity Problem

  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 12496041 ↗
• MalfunctionSep 17, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN INSERTING THE BALLOON CATHETER INTO THE SHEATH, THERE WERE AIR BUBBLES OBSERVED IN THE CO-PILOT. THE CO-PILOT WAS NOTED TO BE LOOSE SO IT WAS TIGHTENED 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 12493052 ↗
• InjurySep 10, 2021Adverse 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) WHILE FREEZING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE PNP DID NOT RECOVER DURING THE CASE, AND THUS 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: Nerve Damage

  MAUDE report 12456769 ↗
• InjurySep 10, 2021Adverse 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 CARDIAC PERFORATION WAS IDENTIFIED VIA ANGIOGRAPHY. THE PULMONARY VEIN ISOLATION PROCEDURE WAS ABORTED DUE TO THE PATIENT SUFFERING A CARDIAC PERFORATION AND THE PATIENT'S UNSTABLE VITAL SIGNS. THE PATIENT EXPERIENCED HYPOTENSION FROM A PERICARDIAL EFFUSION WHICH RESULTED IN CARDIAC TAMPONADE. THE PHYSICIAN PERFORM A PERICARDIOCENTESIS ON THE PATIENT RESULTING IN STABILIZATION OF THE OF PATIENT'S BLOOD PRESSURE, OXYGEN SATURATION LEVELS AND HEART RATE. IT IS UNKNOWN WHICH DEVICE CAUSED THE CARDIAC PERFORATION. THE SHEATH, MAPPING CATHETER AND BALLOON CATHETER HAD ALL ADVANCED INTO THE CARDIAC CHAMBER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 12452954 ↗
• InjuryAug 31, 2021Adverse 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 SUDDEN PHRENIC NERVE INJURY DURING ABLATION OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV). THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS NOTED THAT AFTER 45 MINUTES, THERE WAS SOME RECOVERY OF PHRENIC NERVE PACING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nerve Damage

  MAUDE report 12395072 ↗
• MalfunctionAug 30, 2021Device Contamination with Body Fluid; Material Integrity Problem; Device Contamination with Body Fluid; Material Integrity Problem

  IT WAS REPORTED THAT FOLLOWING SUCCESSFUL CRYO ABLATION PROCEDURE, BLOOD WAS NOTED IN THE COAXIAL UMBILICAL CABLE THAT HAD TRAVELED FROM THE BALLOON CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389504 ↗
• InjuryAug 16, 2021Adverse 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 DEVELOPED A PERICARDIAL EFFUSION RELATED TO A LEFT ATRIAL PUNCTURE THAT DUE TO THE TRANSSEPTAL CROSSING, THAT WAS DETECTED BY INTRACARDIAC ECHOCARDIOGRAPHY. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE BALLOON CATHETER, MAPPING CATHETER, AND SHEATH WERE RETRACTED BACK INTO THE RIGHT ATRIA (RA) WHILE A PERICARDIOCENTESIS WAS PERFORMED. A BLOOD TRANSFUSION WAS REQUIRED AND ANTICOAGULATION WAS REVERSED. A RECONSTITUTED INJECTABLE THROMBIN PRODUCT WAS INJECTED VIA SUB-XYPHOID ACCESS INTO THE PERICARDIAL SPACE TO ASSIST IN HEALING THE PUNCTURE SITE AND STOP BLEEDING INTO THE PERICARDIAL SPACE. THE PATIENT RETURNED TO A STABLE CONDITION FROM THE INTENSIVE CARE UNIT (ICU) AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 12325537 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A COMPLETED CRYOABLATION PROCEDURE WHILE IN THE RECOVERY ROOM, THE PATIENT HAD A STROKE. THE PATIENT WAS UNABLE TO SPEAK AND HAD RIGHT-SIDED PARALYSIS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND THROMBECTOMY WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Paralysis; Stroke/CVA

  MAUDE report 12324983 ↗

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