VikingRecalls & reported problems across all models

We found 9 models of Viking by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2019 and Dec 1, 2025 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. 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 Viking problems

Viking models

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

• Viking™ M0044000070

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  4 reports
• Viking™ M0044000100

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 reports
• Viking™ M0044000470

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 reports
• Viking™ M0044001000

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 reports
• Viking™ M0044000040

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 reports
• Viking™ M0044000160

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 reports
• Viking™ M0044000050

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report
• Viking™ M0044000350

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report
• Viking™ M0044001070

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report

Recent Viking adverse event reports

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

• MalfunctionDec 1, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Positioning Problem; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO ADVANCE, MOVE OR STEER, AND WITHDRAW. A KINK WAS ALSO OBSERVED. DURING AN ELECTROPHYSIOLOGY PROCEDURE TO TREAT ATRIAL FIBRILLATION, A VIKING ELECTRODE CATHETER WAS USED. UPON INSERTION, THE CATHETER BECAME DIFFICULT TO ADVANCE, MOVE OR STEER, AND WITHDRAW IN THE VEIN. THE CATHETER WAS ALSO BENT AND KINKED. NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETER. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RECEIVED, PENDING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679768 ↗
• MalfunctionJun 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT LONG BLACK HAIR WAS NOTED BETWEEN THE LAYERS OF THE INNER PLASTIC PACKAGING. A VIKING ELECTRODE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, THE INNER PACKAGE WAS UNPACKED ON THE STERILE FIELD OF THE LABORATORY TABLE. WHEN THE WHITE PEEL-BACK SEAL WAS OPENED, A LONG BLACK HAIR WAS NOTED BETWEEN THE LAYERS OF THE INNER PLASTIC PACKAGING. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142134 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION DURING THE PROCEDURE WHILE USING A VIKING DECAPOLAR CATHETER. WHEN THE DOCTOR ATTEMPTED TO CANNULATE THE CORONARY SINUS, THE MYOCARDIUM WAS PERFORATED. THE DOCTOR RECALLS THAT THEY MAY HAVE PERFORATED THE CORONARY SINUS VEIN WITH EITHER THE VIKING DECAPOLAR CATHETER OR THE ACUITY EH CATHETER. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT IS EXPECTED TO FULLY RECOVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE WAS DISPOSED BY FACILITY.

  Patient problems: Pericardial Effusion

  MAUDE report 20408878 ↗
• MalfunctionAug 25, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE A VIKING 6F ELECTRODE CATHETER WAS SELECTED FOR USE. UPON UNPACKING, IT WAS FOUND THAT THE DEVICE WAS FRACTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED AT A BOSTON SCIENTIFIC POST MARKET LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625864 ↗
• MalfunctionDec 15, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE USING A VIKING DIAGNOSTIC CATHETER THE DEVICE "WAS WRAPPED INTO THE PATIENT" DURING THE PROCEDURE AND BECAME DIFFICULT TO REMOVE. THEY WERE ABLE TO REMOVE THE CATHETER WITHOUT ADDITIONAL INTERVENTIONS AND THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED OF BY THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987541 ↗
• MalfunctionMay 13, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE A VIKING ELECTRODE CATHETER LOST ITS STIFFNESS AND BENT IN THE PATIENT AND IT WAS DIFFICULT TO REMOVE IT FROM THE PATIENT. THE CATHETER WAS EXCHANGED WITH ANOTHER OF THE SAME TYPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. DEVICE HAS BEEN RECEIVED BY BOSTON SCIENTIFIC AND IS WAITING FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14395641 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, THREE VIKING ELECTRODE CATHETERS, AND AN DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED TAMPONADE. THE EVENT REQUIRED INVASIVE INTERVENTION TO RESOLVE AND PROLONGATION OF HOSPITALIZATION, HOWEVER THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 12920900 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, THREE VIKING ELECTRODE CATHETERS, AND AN DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED TAMPONADE. THE EVENT REQUIRED INVASIVE INTERVENTION TO RESOLVE AND PROLONGATION OF HOSPITALIZATION, HOWEVER THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 12920784 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER, THREE VIKING ELECTRODE CATHETERS, AND AN DYNAMIC XT CATHETER, THE PATIENT EXPERIENCED TAMPONADE. THE EVENT REQUIRED INVASIVE INTERVENTION TO RESOLVE AND PROLONGATION OF HOSPITALIZATION, HOWEVER THE DETAILS OF THE INTERVENTION WERE NOT SPECIFIED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 12920712 ↗
• MalfunctionNov 10, 2021Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING PREPARATION ON THE VIKING ELECTRODE CATHETER, THE "SHAFT OF THE CATHETER TO THE CONNECTION WAS HUNG ON AN EXPOSED CABLE". THE CATHETER WAS NOT USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS STILL COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787167 ↗
• MalfunctionOct 8, 2021Defective Device; Defective Device

  DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER A VIKING ELECTRODE CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT "THERE WAS ERROR IN THE MACHINE" AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598577 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RADIOFREQUENCY (RF) ABLATION WITH A VIKING ELECTRODE CATHETER AND AN INTELLANAV MIFI OPEN-IRRIGATED VIA A 8F SHEATH WAS BEING PERFORMED TO TREAT PREMATURE VENTRICULAR CONTRACTIONS. THE PHYSICIAN PERFORMED ABLATION AFTER 3D MAPPING. THE PHYSICIAN FOUND THE MAPPING POSITION HAD SHIFTED, BUT THE SYSTEM DID NOT ALERT AN ERROR. ABOUT FIFTEEN MINUTES INTO ABLATION, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION NEAR THE LEFT AORTO-MITRAL CONTINUITY (AMC) ORIGIN, SO THE PHYSICIAN STOPPED THE ABLATION. THE PHYSICIAN THEN PERFORMED A PERICARDIOCENTESIS. THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU) FOR FURTHER OBSERVATION AFTER THEY WERE STABILIZED. HOWEVER, THE PATIENT DIED ON (B)(6) 2020 DUE TO CONDITION DETERIORATION. THE PATIENT'S OFFICIAL CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION. THE DEVICES ARE EXPECTED TO BE RETURNED. IT WAS REPORTED THAT THE MAPPING POSITION SHIFT DID NOT CAUSE OR CONTRIBUTE TO THE PERICARDIAL EFFUSION AND SUBSEQUENT DEATH. NO RESISTANCE WAS FELT WHILE MANEUVERING THE CATHETERS.

  Patient problems: Death; Myocardial Infarction; Pericardial Effusion

  MAUDE report 10781456 ↗
• MalfunctionAug 4, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL ON THE OUTER PACKAGE WAS DIFFERENT THAN THE LABEL ON THE INNER PACKAGE.A VIKING CATHETER WAS SELECTED FOR USE. THE MODEL ON THE OUTER PACKAGE WAS FIXED CURVE CATHETER 4E, BUT THE MODEL ON THE INNER ASEPTIC PACKAGE WAS FIXED CURVE CATHETER 10E AND THE DEVICE WAS A FIXED CURVE CATHETER 10E AN EXCHANGE OF THE CATHETER RESOLVED THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10361683 ↗
• MalfunctionJul 30, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL ON THE OUTER PACKAGE WAS DIFFERENT THAN THE LABEL ON THE INNER PACKAGE. DURING AN ARRHYTHMIA PROCEDURE IN THE HEART A VIKING ELECTRODE CATHETER WAS SELECTED FOR USE. THE MODEL OF THE DEVICE WAS DIFFERENT FROM THE OUTER PACKAGE AND INNER PACKAGE. THE OUTER PACKAGE WAS LABELED FIXED CURVE DIAGNOSTIC CATHETER 10E, BUT THE INNER PACKAGE WAS LABELED DIAGNOSTIC CATHETER 4E. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343634 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERFORATION OCCURRED. DURING A BOSTON SCIENTIFIC DEFIBRILLATOR & LEAD IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO CANNULATE THE CORONARY SINUS WITH AN ACUITY PRO GUIDE CATHETER AND A VIKING ELECTRODE CATHETER. DURING THE FIRST ATTEMPT AT CANNULATION, ANGIOGRAPHY SHOWED CONTRAST DYE AROUND THE CARDIAC PROFILE. THE PHYSICIAN CONCLUDED THE IMPLANT PROCEDURE, IMPLANTING A LEFT VENTRICULAR LEAD. THE PATIENT WAS TRANSFERRED TO CARDIOSURGERY WHERE LIQUID DYE AND BLOOD WERE DRAINED TO AVOID PERICARDIAL TAMPONADE. IT WAS NOT POSSIBLE TO DETERMINE WHICH DEVICE(S) HAD CAUSED OR CONTRIBUTED TO THE PERFORATION; IT WAS NOTED THAT "MAYBE BOTH" HAD CONTRIBUTED. AS OF (B)(6) 2019, THE PATIENT WAS "FINE" BUT REMAINED HOSPITALIZED.

  Patient problems: Cardiac Perforation

  MAUDE report 9570571 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports