MobiCath™ D140010 (UDI 00846835012388)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00846835012388), received between Jul 22, 2016 and May 17, 2018 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Packaging Compromised” (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, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE SECOND TRANSSEPTAL PUNCTURE DURING AN ATRIAL FIBRILLATION PROCEDURE THE PHYSICIAN NOTICED A PERICARDIAL EFFUSION ON THE ICE CATHETER. THE CASE WAS ABORTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE CALLER STATED THAT THE PHYSICIAN WAS CONSIDERING SENDING THE PATIENT TO SURGERY AT THE TIME OF THE CALL. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Pericardial Effusion

  MAUDE report 7521578 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC TAMPONADE OCCURRED DURING THE MAPPING PHASE OF THE PROCEDURE. THE CATHETER USED FOR MAPPING WAS THE PENTARAY, AND BEFORE ABLATING, THE CATHETER WENT BACK TO THE RIGHT ATRIUM. IT IS SUSPECTED THAT THE TAMPONADE OCCURED WHEN MANIPULATING THE SHEATHS TO TRY TO REACH THE LEFT ATRIUM AGAIN. THE PROCEDURE WAS STOPPED AND ALL CATHETERS REMOVED FROM THE HEART. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE BLOOD AND PATIENT BECAME STABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 7230726 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: THIS WAS THE THIRD SESSION OF AF ABLATION. AFTER CREATION OF LA VOLTAGE MAP AND ROOF ABLATION, THE PHYSICIAN ABLATED MITRAL ISTHMUS FROM LA ENDOCARDIUM WITH USING MOBICATH SHEATH. THE BLOCK LINE WAS NOT COMPLETED, SO THE PHYSICIAN ABLATED MITRAL ISTHMUS BROADLY. THE CS POTENTIAL WAS NOT SPLIT, AND THE PHYSICIAN ABLATED FROM CS. AFTER THAT THE PHYSICIAN ABLATED FROM LA ENDOCARDIUM AGAIN, THEN THE BLOOD PRESSURE DROPPED DOWN AND PERICARDIAL EFFUSION WAS FOUND BY BODY SURFACE ECHO. THE CARDIAC DRAINAGE WAS PERFORMED WITH ARTERIAL BLOOD, BUT THE PERFORATED SITE WAS UNKNOWN. THIS MADE THE PATIENT RECOVER, SO THE PATIENT WAS BACK TO HOSPITAL ROOM.

  Patient problems: Pericardial Effusion

  MAUDE report 6878702 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED AS REPORTED SUMMARY: WHEN THE PHYSICIAN WAS ABOUT TO START ABLATING AFTER SOUND MERGE AT RA, BB, AND SOUND MERGE AT LA, THE PERICARDIAL EFFUSION WAS CONFIRMED BY SOUNDSTAR CATHETER. THE DROP OF BLOOD PRESSURE AND THE ABNORMALITY OF ECG WERE NOT OBSERVED, AND PERICARDIAL EFFUSION WAS NOT OBSERVED OBVIOUSLY BY TRANSTHORACIC ECHO TOO. CONSIDERING THE WORST CASE, HOWEVER, THE PROCEDURE WAS ENDED AND THE PATIENT LEFT ROOM.

  Patient problems: Pericardial Effusion

  MAUDE report 6878635 ↗
• MalfunctionFeb 3, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED THAT THE STERILE POUCH WASN'T CLOSED. THE DEVICE WAS REPLACED PRIOR TO USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301554 ↗
• MalfunctionFeb 3, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING, THE TOP OF THE PACKAGING WAS NOT SEALED PROPERLY; THE DEVICE WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301548 ↗
• MalfunctionFeb 3, 2017Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING ONE END WAS NOT SEALED AND THE DEVICE DROPPED ON THE GROUND. THE DEVICE WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301546 ↗
• InjuryJan 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER GOING TRANSEPTAL BUT BEFORE ABLATION THE PATIENT'S BLOOD PRESSURE DROPPED SLIGHTLY AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIAL EFFUSION WAS PERFORMED AND THE CASE WAS CONTINUED. THE MOBICATH STEERABLE SHEATH WAS USED AS PART OF THIS PROCEDURE. THE FOLLOWING BWI DEVISES WERE ALSO IN USE: STSF, CARTO, AND SMART ABLATE GENERATOR.

  Patient problems: Pericardial Effusion

  MAUDE report 6257666 ↗
• MalfunctionJul 22, 2016Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE SIDE PORT ON THE MOBI CATHETER FELL OFF OF THE SHEATH. THE PHYSICIAN REPLACED THE PRODUCT AND CONTINUED WITH THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5815980 ↗