ACHIEVE ADVANCERecalls & reported problems across all models

We found 3 models of ACHIEVE ADVANCE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between May 24, 2017 and Aug 11, 2025 — classified as 3 deaths, 28 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ACHIEVE ADVANCE problems

ACHIEVE ADVANCE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ACHIEVE ADVANCE™ 2ACH20

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 deaths69 reports
• ACHIEVE ADVANCE™ 2ACH15

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  7 reports
• ACHIEVE ADVANCE™ 2ACH25

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 reports

Recent ACHIEVE ADVANCE adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, A CIRCULAR MAPPING LEAD WAS FOUND TO BE KINKED DURING PLACEMENT. THE SURGEON REQUESTED THE REPLACEMENT OF THE KINKED CIRCULAR MAPPING LEAD. THE PROCEDURE 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 21045182 ↗
• MalfunctionDec 2, 2024Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A MAPPING CATHETER, THERE WAS DIFFICULTY INSERTING THE MAPPING CATHETER INTO THE BALLOON. UPON SUCCESSFUL INSERTION, A DEFORMED LOOP AND PHYSICAL DAMAGE, SPECIFICALLY A TIP/LOOP KINK, WERE OBSERVED ON THE MAPPING CATHETER. THE MAPPING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE PROCEDURE 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 20819569 ↗
• MalfunctionAug 27, 2024Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PROXIMAL END OF THE MAPPING CATHETER WAS BENT AND BROKEN, LEADING TO SIGNAL ISSUES. MULTIPLE ATTEMPTS WERE MADE TO RESTORE THE DEVICE WITH NO RESOLUTION. THE MAPPING CATHETER WAS 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 20075457 ↗
• MalfunctionAug 12, 2024Signal Artifact/Noise; Compatibility Problem; Material Twisted/Bent; Signal Artifact/Noise; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS NOISE ON ELECTRODES ONE, TWO, AND THREE. IT WAS THEN REPORTED THAT WHEN RETRACTING THE MAPPING CATHETER INTO THE BALLOON CATHETER, THERE WAS RESISTANCE. ADDITIONALLY, AFTER THE MAPPING CATHETER WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE LOOP WAS KINKED. THE MAPPING CATHETER WAS 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 19962530 ↗
• 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 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT WAS RUSHED TO THE SURGICAL DEPARTMENT FOR EMERGENCY TREATMENT BUT THE SPECIFIC INTERVENTION IS UNKNOWN. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AND IS STILL CURRENTLY HOSPITALIZED.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 19599859 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE, THE PATIENT LABS SHOWED HYPONATREMIA, HYPOKALEMIA, HYPOCALCEMIA, AND A SLIGHTLY ELEVATED WHITE BLOOD CELL (WBC) COUNT. AN ELECTROLYTE SUPPLEMENT WAS ADMINISTERED INTRAVENOUSLY TO THE PATIENT TO TREAT THE HYPOKALEMIA. DESPITE THE PATIENT BEING IN SINUS RHYTHM, THE PATIENT WAS CARDIOVERTED THE FOLLOWING DAY. THE PATIENT WAS ALSO HOSPITALIZED OVERNIGHT. 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; High White Blood Cell Count; Hypocalcemia; Hypokalemia; Hyponatremia

  MAUDE report 19200660 ↗
• InjuryFeb 9, 2024Signal Artifact/Noise; Entrapment of Device; Detachment of Device or Device Component; Signal Artifact/Noise; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE INTEGRATED DILATOR/NEEDLE WAS NOT ABLE TO LOCK INTO THE SHEATH. THE DILATOR/NEEDLE WAS REPLACED WHICH RESOLVED THE ISSUE. AFTER THE FIRST ABLATION IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV), THE MAPPING CATHETER HAD A LOT OF NOISE. THE MAPPING CATHETER CABLE REPLACED, AND THEN THE PIN BLOCK WAS REPLACED WITHOUT RESOLUTION. THE PHYSICIAN ATTEMPTED TO REPOSITION THE MAPPING CATHETER AND IT WAS NOTED THAT IT DID NOT MOVE AT ALL. WHEN THE PHYSICIAN PULLED THE MAPPING CATHETER ALL THE WAY BACK, THE END OF MAPPING CATHETER REMAINED LODGED IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE BALLOON CATHETER WAS REMOVED; A SNARE WAS INSERTED, AND THE END OF THE MAPPING CATHETER WAS SNARED, PULLED BACK INTO THE SHEATH, AND REMOVED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Physical Entrapment

  MAUDE report 18680541 ↗
• MalfunctionJan 29, 2024Compatibility Problem; Material Deformation; Material Twisted/Bent; Compatibility Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WOULD NOT ADVANCE INTO THE BALLOON CATHETER GUIDEWIRE LUMEN. THE MAPPING CATHETER WAS DAMAGED. THE MAPPING CATHETER AND BALLOON CATHETER 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 18603434 ↗
• MalfunctionDec 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER HAD A KINK IN THE SHAFT. THE MAPPING CATHETER WAS REPLAC ED 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 18377874 ↗
• InjuryOct 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS FOLLOWING A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT HAD ATRIAL FLUTTER WITH A RAPID VENTRICULAR RATE. A BLOOD TEST AND X-RAY WERE SUBSEQUENTLY PERFORMED, BOTH WITH NO CLINICALLY SIGNIFICANT RESULTS, AND THE PATIENT WAS HOSPITALIZED OVERNIGHT. 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 Fibrillation; Atrial Flutter

  MAUDE report 18027265 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE MAPPING CATHETER WAS SUSPECTED TO HAVE PERFORATED THE LEFT SUPERIOR PULMONARY VEIN (LSPV). THE PATIENT REMAINED HOSPITALIZED, INTUBATED, AND STABLE TWO WEEKS FOLLOWING THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 17920051 ↗
• InjuryOct 5, 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, FIRST AND ONLY FREEZE ON THE LEFT INFERIOR BRANCH OF THE LEFT COMMON VEIN, A POTENTIAL BLOOD CLOT WAS SUSPECTED DISTAL TO THE BALLOON INSIDE THE VEIN. THE FREEZE WAS CARRIED OUT. IMAGING WAS USED TO VERIFY IF THE CLOT WAS PRESENT BUT IT COULD NOT BE CONFIRMED. BLOOD THINNING MEDICATION WAS ADMINISTERED PRIOR TO THE TRANSEPTAL PUNCTURE AND AN ACTIVATED CLOTTING TIME (ACT) WAS ALSO COLLECTED BEFORE INSERTING THE BALLOON INTO THE LEFT ATRIUM. THE PATIENT REMAINED STABLE AND SHOWED NO SIGNS OF ST ELEVATION. THE CASE WAS COMPLETED WITH CRYO. THERE WAS NO EFFUSION POST ABLATION AND AGAIN THE IMAGE OF THE POTENTIAL BLOOD CLOT COULD NOT BE REPRODUCED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17875560 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls