ACHIEVE™ 990063-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169467378), received between Feb 12, 2018 and Oct 10, 2024 — classified as 2 deaths, 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K102588); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE THAT REQUIRED TREATMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED WHILE ANOTHER MANUFACTURER'S RADIOFREQUENCY (RF) CATHETER WAS BEING USED IN THE PATIENT'S SUPERIOR VENA CAVA (SVC). IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A PERFORATION. THE INJURIES WERE TREATED WITH A PERICARDIOCENTESIS AND TAP. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED.

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 17944874 ↗
• MalfunctionSep 12, 2023Compatibility Problem; Material Twisted/Bent; Compatibility Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WOULD NOT INSERT INTO THE BALLOON CATHETER AS EXPECTED. THE MAPPING CATHETER WAS INSPECTED AND THE INTRODUCER FELT THICKER THAN USUAL. 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 17730239 ↗
• MalfunctionDec 6, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, NOISE WAS HEARD COMING FROM TWO ELECTRODES ON THE MAPPING CATHETER. THE MAPPING CATHETER CABLE WAS REPLACED WITHOUT RESOLUTION. SUBSEQUENTLY, 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 15928719 ↗
• MalfunctionNov 28, 2022Signal Artifact/Noise; Material Deformation; Material Twisted/Bent; Signal Artifact/Noise; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER SIGNAL WAS LOST ON SEVERAL ELECTRODES DURING THE SECOND ABLATION. EVENTUALLY, THE MAPPING CATHETER WAS COMPLETELY NON-RESPONSIVE. IT WAS ALSO REPORTED THAT THE BALLOON CATHETER WAS DIFFICULT TO POSITION. AFTER REMOVING THE MAPPING CATHETER, A BEND WAS OBSERVED IN THE SHAFT. 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 15870391 ↗
• InjuryNov 23, 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, 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. AFTER COMPLETING THE ABLATION OF THE LEFT INFERIOR PULMONARY VEIN (LIPV), AN EFFUSION WAS IDENTIFIED. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS SUBJECTED TO AN EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PER THE PHYSICIAN, THE CAUSE OF THE PERFORATION IS UNKNOWN. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 15859330 ↗
• InjuryAug 10, 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, WHILE LOCATING THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WITH THE MAPPING CATHETER THE SHEATH FELL OUT OF THE LEFT ATRIUM.  IT WAS NOTED THAT THE PATIENT¿S CO2 LEVEL DROPPED AND AN INTRACARDIAC ECHOCARDIOGRAM DETECTED THE PERICARDIAL CAVITY WAS FILLED WITH BLOOD AND CAUSED CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE BLOOD FROM THE CAVITY, HOWEVER THE PERICARDIAL CAVITY CONTINUED TO FILL WITH BLOOD. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND STABILIZED FOR TRANSFER FOR EXPLORATORY SURGERY. A TEAR IN THE LEFT ATRIUM ROOF WAS FOUND AND REPAIRED. THE PATIENT WAS BROUGHT TO INTENSIVE CARE UNIT (ICU) POST-SURGERY AND WAS EXTUBATED THE NEXT DAY. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA. NO OTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 15202292 ↗
• MalfunctionMay 10, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS BENT AND COULD NOT BE INSERTED INTO THE BALLOON CATHETER. THE MAPPING CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349163 ↗
• 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 12590967 ↗
• 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 12325546 ↗
• InjuryJun 28, 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 BALLOON CATHETER AND SHEATH FELL OUT OF THE LEFT ATRIUM DURING AN ABLATION. WHEN THE SYSTEM WAS ADVANCED A PERFORATION WAS CAUSED IN THE RIGHT ATRIUM. A PERICARDIAL EFFUSION OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT RECOVERED. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 12075410 ↗
• MalfunctionMay 20, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT FOLLOWING A CRYO ABLATION PROCEDURE, WHEN THE MAPPING CATHETER WAS REMOVED, THE TIP WAS DAMAGED IN THE REMOVAL PROCESS. 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 11855615 ↗
• MalfunctionMar 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS DIFFICULT TO MANEUVER AND IT WAS NOTED THAT THE SHAFT HAD AN ACUTE BEND. IT WAS ALSO REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON CATHETER INTO THE SHEATH AND A VISIBLE KINK WAS NOTED ON FLUOROSCOPY ON THE DISTAL PORTION OF THE SHEATH. THE MAPPING CATHETER AND SHEATH WERE 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 11515649 ↗
• InjuryDec 15, 2020Adverse 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 ABLATING THE POSTERIOR WALL, THE PATIENT DEVELOPED HEART BLOCK AND HYPOTENSION. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. CARDIOPULMONARY RESUSCITATION (CPR) WAS GIVEN. THE PATIENT WAS HOSPITALIZED, AND RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 11013179 ↗
• DeathNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMMEDIATELY FOLLOWING A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. AFTER ASSESSMENT OF THE PATIENT, AN EFFUSION WAS CONFIRMED. A PERICARDIOCENTESIS TAP AND A STERNOTOMY WERE ATTEMPTED WITHOUT SUCCESS. THE PATIENT EXPIRED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10884342 ↗
• MalfunctionOct 28, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WAS NOT MOVING AS EXPECTED AND WAS STUCK IN A "COILED POSITION." THE MAPPING CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9246967 ↗
• MalfunctionOct 21, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER DISTAL LOOP WOULDN'T MAINTAIN ITS SHAPE. THE MAPPING CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9212693 ↗
• MalfunctionJun 6, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER APPEARED TO BE KINKED. THE MAPPING CATHETER WAS REPLACED AND WAS ABLE TO BE INSERTED INTO THE BALLOON CATHETER SUCCESSFULLY. THE CASE WAS COMPLETED WITH RADIOFREQUENCY (RF). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675322 ↗
• DeathApr 24, 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, THE RIGHT INFERIOR PULMONARY VEIN (RIPV) WAS PERFORATED. ADDITIONALLY, THE PHYSICIAN NOTICED BLOOD IN THE ENDOTRACHEAL (ET) TUBE. BLOOD WAS SUCTIONED FROM THE ET TUBE, BUT BLEEDING CONTINUED, AND THE CASE HAD TO BE ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT IS DECEASED.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 8547221 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INCOMING INFORMATION RECEIVED THAT THE MAPPING CATHETER WAS RESPONSIBLE FOR THE PERFORATION OF THE PULMONARY VEIN. ADDITIONALLY, THE PATIENT DID NOT HAVE TO GO TO THE OPERATING ROOM FOR SURGICAL REPAIR AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

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

  MAUDE report 8203063 ↗
• MalfunctionOct 19, 2018Material Twisted/Bent; Material Twisted/Bent

  THE MAPPING CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7985306 ↗
• MalfunctionJun 29, 2018Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, AN ELECTRODE ON THE MAPPING CATHETER WAS NOT FUNCTIONING PROPERLY. THE MAPPING CATHETER WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651669 ↗
• MalfunctionJun 29, 2018Kinked; Kinked

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE ELECTRODES ON THE MAPPING CATHETER WERE NOT FUNCTIONING PROPERLY. THE CASE WAS COMPLETED WITH CRYO. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102588. One submission often covers many models, so check the product and lot details in each record.

• Z-0200-2016 · Sep 29, 2015 · Terminated
  Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter