ACHIEVE™ 990063-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00643169467385), received between Feb 7, 2017 and Dec 9, 2025 — classified as 7 deaths, 49 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (47 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. 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 129 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 30, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER WOULD NOT PASS THROUGH LUMEN OF THE BALLOON CATHETER. INTRODUCER WAS WORKING PROPERLY. THE COPILOT WAS ADJUSTED WITHOUT RESOLVE. THE MAPPING CATHETER WAS REPLACED WITHOUT RESOLVE. THE BALLOON CATHETER WAS THEN 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 18028601 ↗
• MalfunctionOct 12, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER BECAME DAMAGED WHILE ATTEMPTING TO ADVANCE IT 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 17928140 ↗
• InjurySep 20, 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, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. IT WAS FURTHER REPORTED THAT THE EFFUSION OCCURRED FOLLOWING ABLATION OF THE LEFT SUPERIOR PULMONARY VEIN (LSPV), LEFT ATRIAL APPENDAGE, AND RIGHT SUPERIOR PULMONARY VEIN (RSPV). IT WAS NOTED THAT THE PATIENT EXPERIENCED A SIGNIFICANT DROP IN BLOOD PRESSURE, AND THE PHYSICIAN VISUALIZED A SIGNIFICANT EFFUSION USING AN INTRACARDIAC ULTRASOUND CATHETER. A PERICARDIOCENTESIS WAS QUICKLY PERFORMED AND 1100 ML OF BLOOD WAS REMOVED. THE PATIENT LEFT THE LAB IN STABLE CONDITION AND WAS MONITORED FOR FURTHER DRAINAGE FROM THE PERICARDIUM. THE PATIENT WAS IN THE HOSPITAL FOR TWO DAYS FOLLOWING THE EVENT AND WAS DISCHARGED HOME WITHOUT ANY FURTHER INTERVENTION OR ISSUE. 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: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 17784365 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2023-08-23, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PHYSICIAN BELIEVED THAT THE PATIENT'S PRE-EXISTING CONDITION RELATED TO HIS LONG-TIME SMOKING AND COUGHING WAS THE CAUSE OF THE PULMONARY BLEED. IT WAS NOTED THAT THE PHYSICIAN BELIEVED THAT THE BLEEDING WAS CAUSED OR MADE WORSE BY THE PATIENT RECEIVING AN ANTICOAGULANT AND THAT THE SYMPTOMS APPEARED SHORTLY AFTER THE ANTICOAGULANT WAS GIVEN. IT WAS REPORTED THAT THERE WAS NO EVIDENCE THAT THE TRANSSEPTAL PROCEDURE OR THE MANIPULATION OF THE BALLOON CATHETER AND MAPPING CATHETER WERE RELATED TO THE LOCATION OF THE BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17152862 ↗
• MalfunctionMay 19, 2023Signal Artifact/Noise; Material Twisted/Bent; Signal Artifact/Noise; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS NO SIGNAL ON SEVERAL OF THE MAPPING CATHETER ELECTRODES. 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 16962566 ↗
• MalfunctionMay 17, 2023Material Twisted/Bent; Insufficient Device Problem Information; Material Twisted/Bent; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, CONTRAST WAS UNABLE TO BE INJECTED THROUGH THE BALLOON CATHETER. THE MAPPING CATHETER WAS NOTED TO HAVE A THICKENED AREA ON IT APPROXIMATELY A COUPLE INCHES FROM THE TIP. THE BALLOON CATHETER AND MAPPING CATHETER 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 16949965 ↗
• MalfunctionMay 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE FOR A CRYO ABLATION PROCEDURE WHILE TAKING THE MAPPING CATHETER OUT OF THE PACKAGING, A KINK WAS OBSERVED TO PROXIMAL END OF THE MAPPING CATHETER. THE MAPPING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860333 ↗
• MalfunctionApr 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A COMPROMISED OUTER VACUUM. WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT, THE MAPPING CATHETER WAS KINKED INSIDE OF THE COPILOT. THE BALLOON CATHETER AND MAPPING CATHETER WERE 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 16786288 ↗
• MalfunctionMar 24, 2023Signal 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 RESISTANCE FELT WHEN THE MAPPING CATHETER WAS BROUGHT BACK INTO THE SHEATH. THE SIGNAL WAS THEN LOST. THE MAPPING CATHETER WAS ADJUSTED WITHOUT RESOLVE. THE MAPPING CATHETER WAS MOVED AROUND THE HEART AND SIGNAL WAS FURTHER LOST. 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 16613498 ↗
• MalfunctionMar 22, 2023Material Deformation; Material Twisted/Bent; Device Handling Problem; Material Deformation; Material Twisted/Bent; Device Handling Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE MAPPING CATHETER APPEARED BENT AT THE BASE FOLLOWING ACCESS OF THE LOWER BRANCH OF THE LEFT COMMON PULMONARY VEIN. THE BALLOON CATHETER AND MAPPING CATHETER WERE REMOVED FROM THE BODY AND SEPARATED. THE LOOP OF THE MAPPING CATHETER WAS KINKED. THE MAPPING CATHETER WAS MORE DIFFICULT TO MANEUVER AFTER THE KINK OCCURRED. 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 16591849 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SMALL PERICARDIAL EFFUSION WAS FOUND DURING A CRYO ABLATION PROCEDURE. TO ADD, THIS WAS AFTER THE TRANSEPTAL PUNCTURE WAS CARRIED OUT. IT IS UNCLEAR IF THE MEDTRONIC PRODUCTS CONTRIBUTED TO THE PERICARDIAL EFFUSION. THE CASE WAS ABORTED UNDER GENERAL ANESTHESIA. THE PATIENT WAS NOT HOSPITALIZED OR PROLONGED DUE FOR THE EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion

  MAUDE report 16590748 ↗
• MalfunctionFeb 27, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHEN THE MAPPING CATHETER WAS CONNECTED AND INSERTED INTO THE PATIENT, THE MAPPING CATHETERS SEVENTH AND EIGHT ELECTRODE WERE EXPERIENCING NOISE. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE ELECTRODES SEVEN AND EIGHT WERE REMOVED 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 16449206 ↗
• MalfunctionJan 30, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, RESISTANCE WAS OBSERVED WHEN ATTEMPTING TO LOAD THE MAPPING CATHETER THROUGH THE COPILOT OF THE BALLOON CATHETER. IT WAS CONFIRMED THAT THE BLUE INTRODUCER WAS DEEP SEATED INTO THE COPILOT AND THAT THE COPILOT WAS LOOSENED. THE MAPPING CATHETER WAS REMOVED FOR INSPECTION OF KINKS OR ABNORMALITIES, AND A WHITE SHAVING WAS FOUND HANGING FROM THE TIP OF THE MAPPING CATHETER. IT IS UNKNOWN WHETHER THIS WHITE SHAVING CAME FROM THE STERILE FIELD OR ELSEWHERE. THE SHAVING WAS REMOVED, BUT RESISTANCE WAS STILL FELT WHEN ATTEMPTING TO LOAD THE MAPPING CATHETER THROUGH THE COPILOT OF THE BALLOON CATHETER. A SECOND STAFF MEMBER ATTEMPTED TO ASSIST BUT EXPERIENCED THE SAME DIFFICULTIES. THE PHYSICIAN THEN ATTEMPTED TO LOAD THE MAPPING CATHETER BUT THE ISSUES PERSISTED. A NEW BALLOON CATHETER WAS USED AND THE MAPPING CATHETER SUCCESSFULLY ADVANCED INTO THE COPILOT. 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 16264692 ↗

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