ACHIEVERecalls & reported problems across all models

We found 2 models of ACHIEVE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 156 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2017 and Dec 9, 2025 — classified as 9 deaths, 58 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (57 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 problems

ACHIEVE models

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

• ACHIEVE™ 990063-020

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  7 deaths129 reports
• ACHIEVE™ 990063-015

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 deaths27 reports

Recent ACHIEVE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryDec 9, 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, A PATIENT DEVELOPED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABILIZED IN THE ELECTROPHYSIOLOGY LAB BEFORE BEING TRANSFERRED TO THE INTENSIVE CARE UNIT FOR RECOVERY WITH THE DRAIN IN PLACE. THE PATIENT REQUIRED UNEXPECTED HOSPITALIZATION. THE PROCEDURE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 23761221 ↗
• MalfunctionDec 3, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS LATER REPORTED THAT THE DAMAGE WAS ON THE SHAFT OF THE CATHETER, NOT THE LOOP OR THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708768 ↗
• InjuryOct 30, 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, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. IT WAS FURTHER REPORTED THAT THE ACCESS TO THE LEFT ATRIUM WAS LOST AND WHEN THE PHYSICIAN ATTEMPTED TO REGAIN ACCESS, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. A PERICARDIAL EFFUSION WAS FOUND ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A PERICARDIOCENTESIS WAS PERFORMED AND A DRAIN WAS LEFT IN THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FLOOR AND HOSPITALIZATION WAS EXTENDED. IT WAS NOTED THAT NEITHER A DILATOR, NEEDLE, NOR A GUIDEWIRE WERE USED IN THE ATTEMPT TO REGAIN TRANSSEPTAL ACCESS. ADDITIONALLY, THE PHYSICIAN ALLEGED THAT A TAMPONADE CONTRIBUTED TO THE PERICARDIAL EFFUSION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT HAS BEEN DISCHARGED TO HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20566337 ↗
• DeathOct 23, 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, THE PATIENT HAD HYPOTENSION, PERICARDIAL EFFUSION, AND CARDIAC TAMPONADE. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A PERICARDIOCENTESIS WAS PERFORMED AND THEN THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS SURMISED TO BE PERICARDIAL EFFUSION AND CARDIAC TAMPONADE.

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

  MAUDE report 20515182 ↗
• MalfunctionOct 10, 2024Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS NOISE FROM THE MAPPING 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 20417751 ↗
• InjuryOct 7, 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, TRANSSEPTAL ACCESS WAS DIFFICULT TO OBTAIN WITH THE SHEATH. FOLLOWING THE LAST ABLATION, AN EFFUSION AROUND THE VENTRICLE WAS OBSERVED. PERICARDIOCENTESIS WAS SUBSEQUENTLY PERFORMED. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 20390905 ↗
• MalfunctionJun 26, 2024Mechanical Problem; Compatibility Problem; Material Twisted/Bent; Mechanical Problem; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS DIFFICULTY INSERTING THE MAPPING CATHETER INTO THE SHEATH. PRIOR TO INSERTION INTO THE PATIENT, THE MAPPING CATHETER LOOP WAS OBSERVED TO BE MISSHAPEN WHILE EXTENDING OUT OF 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 19615601 ↗
• MalfunctionApr 19, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN PREPPING THE MAPPING CATHETER THERE WAS DIFFICULTY INSERTING THE MAPPING CATHETER INTO THE CO-PILOT. THE MAPPING CATHETER WAS NOTED TO BE KINKED ON THE PROXIMAL END OF THE SHAFT. THE MAPPING 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 19141645 ↗
• MalfunctionMar 27, 2024Mechanical Problem; Compatibility Problem; Material Deformation; Mechanical Problem; Compatibility Problem; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE DILATOR COULD NOT BE LOCKED INTO THE SHEATH. THE SHEATH WAS REPLACED, BUT THE SAME ISSUE OCCURRED. THE SHEATH WAS REPLACED AGAIN WHICH RESOLVED THE ISSUE. IT WAS THEN REPORTED THAT A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE AUTO CONNECTION BOX AND ELECTRICAL UMBILICAL CABLE WERE REPLACED, BUT THE ISSUE PERSISTED. THE BALLOON CATHETER WAS THEN REPLACED WHICH RESOLVED THE SYSTEM NOTICE. IT WAS ALSO REPORTED THAT WHEN REPLACING THE BALLOON CATHETER, WHEN ADVANCING THE MAPPING CATHETER INTO THE BALLOON CATHETER RESISTANCE WAS FELT, THE MAPPING CATHETER BECAME KINKED. 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 18985595 ↗
• MalfunctionMar 21, 2024Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DID NOT RECOGNIZE THE CATHETER. THE BALLOON CATHETER WAS REPLACED TO RESOLVE THE ISSUE. IT WAS ALSO REPORTED THAT THE MAPPING CATHETER WAS DAMAGED AND THE LOOP WAS "NOT TRUE" AND UNABLE TO HOLD ITS SHAPE AFTER EXITING THE SHEATH. 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 18952215 ↗
• InjuryMar 19, 2024Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT HAD A SMALL BASELINE EFFUSION AND LOW BLOOD PRESSURE COMING INTO THE PROCEDURE. IT WAS ALSO REPORTED THAT DUE TO UNSTABLE BLOOD PRESSURE, THERE WAS A CONCERN THAT THE EFFUSION MAY HAVE BEEN GROWING DUE TO A PERFORATION. AFTER ATTEMPTING PERICARDIOCENTESIS, IT WAS SURMISED THAT THE PATIENT DID NOT HAVE AN ACTIVELY BLEEDING PERFORATION OF GROWING EFFUSION.

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

  MAUDE report 18936597 ↗
• MalfunctionFeb 7, 2024Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS NOISE ON ELECTRODES ONE TO FOUR. THE MAPPING CATHETER CABLE WAS REPLACED WITHOUT RESOLUTION. 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 18663668 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS DIFFICULTY ATTEMPTING TO CANNULATE THE RIGHT INFERIOR PULMONARY VEIN (RIPV). EVENTUALLY THE TRANSEPTAL WAS LOST. THE MAPPING CATHETER WAS THEN REMOVED AND DAMAGE WAS NOTED; THE MAPPING CATHETER WAS "STRETCHED OUT." THE MAPPING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, WHILE ATTEMPTING TO ADVANCE THE SHEATH, IT WOULD NOT ADVANCE INTO THE GROIN. ANOTHER DILATOR WAS USED WITHOUT RESOLVE. THE SHEATH WAS REMOVED FROM THE WIRE AND A BIGGER DISSECTION WAS MADE INTO THE TISSUE WITHOUT RESOLVE. THE SHEATH TIP WAS NOTED TO BE BENT. THE SHEATH 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 18646446 ↗
• InjuryJan 25, 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, AFTER COMPLETE RIGHT INFERIOR PULMONARY VEIN (RIPV) ABLATION AND SOME RIGHT SUPERIOR PULMONARY VEIN (RSPV) ABLATION, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. AFTER THREE FREEZES IN THE RSPV AND TWO FREEZES IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV), THE PATIENT'S BLOOD PRESSURE DROPPED LOWER THAN EXPECTED. A PERICARDIAL EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT'S CHEST WAS THEN PREPPED AND ACCESSED; BLOOD WAS ASPIRATED FROM THE PERICARDIUM. THE PATIENT WAS THEN STABILIZED AND TRANSFERRED TO THE OPERATING ROOM WHERE A TEAR WAS FOUND ON THE RIGHT CARINA IN THE LEFT ATRIUM, BETWEEN THE LSPV AND LEFT INFERIOR PULMONARY VEIN (LIPV). THE TEAR WAS REPAIRED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OVERNIGHT HOSPITALIZATION. THE PATIENT REMAINS IN THE ICU, IS STABLE, AND IS "DOING WELL." 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 18583099 ↗
• MalfunctionJan 9, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER KINKED AND COULD NOT BE INSERTED BACK 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 18476124 ↗

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