ACHIEVE ADVANCE™ 2ACH15Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169590960), received between Jul 23, 2019 and Aug 11, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE USING THE CATHETER AFAPRO23 AFA PRO 23, THE PATIENT EXPERIENCED ST SEGMENT ELEVATION AFTER THE FIRST CRYO ABLATION IN THE LEFT INFERIOR PULMONARY VEIN. FREEZE PARAMETERS WERE NORMAL AT -63 DEGREES FOR 180 SECONDS, AND THE ONSET OF ST SEGMENT ELEVATION OCCURRED 2 MINUTES AND 45 SECONDS INTO THE FREEZE. INTERVENTIONAL CARDIOLOGY WAS CONTACTED, AND 10MG INTRAVENOUS VASODILATOR MEDICATION WAS ADMINISTERED. THE PROCEDURE WAS ABORTED UNDER GENERAL ANESTHESIA. CORONARY ANGIOGRAPHY REVEALED COMPLETED OCCLUSION OF THE RIGHT CORONARY ARTERY AND CHRONIC CORONARY ARTERY DISEASE IN THE LEFT MAIN/LEFT ANTERIOR DESCENDING ARTERIES. THE PATIENT EXHIBITED SMALL RUNS OF VENTRICULAR TACHYCARDIA AND PREMATURE VENTRICULAR CONTRACTIONS, WHICH WERE TREATED WITH 150MG OF AN ANTIARRHYTHMIC MEDICATION. AN INTERVENTIONALIST INJECTED 300MCG INTRACORONARY VASODILATOR MEDICATION INTO THE AORTIC ROOT/RIGHT CORONARY ARTERY, WHICH IMMEDIATELY RESOLVED THE ST SEGMENT ELEVATION. THE EVENT WAS DIAGNOSED AS ACUTE CORONARY SPASM. THE PATIENT WAS STABLE, TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MEDICAL MANAGEMENT, AND UNDERWENT A COMPUTED TOMOGRAPHY SURG

  Patient problems: Cramp(s) /Muscle Spasm(s); Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 22772148 ↗
• MalfunctionMar 26, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, THERE WERE ISSUES WITH INSERTING THE MAPPING CATHETER INTO THE BALLOON CATHETER. POST ABLATION, THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT IN ORDER TO POST MAP AND CHECK PULMONARY VEIN ISOLATION. UPON ATTEMPTING TO REINSERT THE BALLOON CATHETER FOR FURTHER ABLATIONS, THE CATHETER BECAME DIFFICULT TO PASS THROUGH THE FLEXCATH SHEATH. A KINK WAS OBSERVED IN THE BALLOON CATHETER NEAR THE DISTAL END. THE BALLOON CATHETER WAS RE-PREPPED BUT THEN THE MAPPING CATHETER WOULD NOT ADVANCE TO THE END OF THE BALLOON. A KINK WAS ALSO NOTED IN THE MAPPING CATHETER WHEN REMOVED. BOTH THE BALLOON AND MAPPING CATHETERS WERE REPLACED. 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 21704053 ↗
• MalfunctionJul 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER HAD A SHAFT KINK. THE MAPPING CATHETER WAS SUBSEQUENTLY REPLACED. 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 19680197 ↗
• MalfunctionJun 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER BENT WHILE BEING INSERTED INTO THE BALLOON CATHETER AT THE BLUE AND BLACK JUNCTION. THE MAPPING CATHETER WAS SUBSEQUENTLY REPLACED. 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 17182669 ↗
• MalfunctionNov 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS KINKED WHEN INSERTED INTO THE BALLOON CATHETER. THE MAPPING 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 15830503 ↗
• InjuryOct 1, 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, BLOOD WAS OBSERVED IN THE ENDOTRACHEAL TUBE. A BRONCHOSCOPY WAS PERFORMED AND IT WAS DISCOVERED THAT THE LEFT INFERIOR PULMONARY VEIN (LIPV) HAD BEEN PERFORATED. THE ANTICOAGULANT WAS REVERSED AND THE PROCEDURE WAS IMMEDIATELY ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A BALLOON SEALING APPARATUS WAS APPLIED TO SEAL OFF THE BLEEDING. THE PATIENT'S HEMODYNAMICS REMAINED STABLE THROUGHOUT THE PROCEDURE AND BRONCHOSCOPY. THE PATIENT WAS THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND REMAINED INTUBATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15525207 ↗
• InjuryJul 23, 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, PRIOR TO THE START OF THE PROCEDURE, AN EFFUSION WAS OBSERVED VIA INTRA CARDIAC ECHOCARDIOGRAPHY. THE PHYSICIAN CONTINUED THE CASE AND WAS ABLE TO COMPLETE WITH CRYO. FOLLOWING THE CASE, THE EFFUSION WAS INDICATED TO BE LARGER. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT'S HOSPITAL STAY WAS EXTENDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 8818093 ↗