MOBICATH™ D140010 (UDI 00821329400995)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821329400995), received between Jan 30, 2018 and Feb 2, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DURING SVC ISOLATION, PHRENIC NERVE PARALYSIS OCCURRED DURING FREE WALL ABLATION. ABLATION WAS DISCONTINUED IMMEDIATELY, BUT PARALYSIS DID NOT RETURN, AND THE PATIENT LEFT THE ROOM. DIAPHRAGMATIC NERVE PARALYSIS. THE PHRENIC NERVE PALSY REMAINED WHEN THE PATIENT LEFT THE ROOM. THE PHYSICIAN COMMENTED THAT NOTHING IN PARTICULAR" NO ALLEGATIONS WERE MADE AGAINST THE MOBICATH SHEATH.

  Patient problems: Nerve Damage

  MAUDE report 13423797 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DETAILED CIRCUMSTANCES AT THE TIME OF OCCURRENCE (ALWAYS STATED IF AN ERROR CODE IS KNOWN): PVI, AFTER CTI ISOLATION, WHEN TRIGGERED FROM CS, AT OCCURRED DURING MAPPING BLOOD PRESSURE DROPPED, IT WAS CHECKED BECAME CARDIAC TAMPONADE BY ECHOCARDIOGRAPHY. DURING ABLATION BLOOD PRESSURE DID NOT DROP SUDDENLY, IT WAS UNKNOWN AT WHAT TIMING IT BECAME A DANDELION. TIMING WHEN COMPLAINTS OCCURRED: AFTER 3 HOURS SINCE THE PROCEDURE WAS STARTED PVC, AFTER CTI ISOLATION, DURING ATMAPPING HOW TO COMPLETE THE PROCEDURE: PERFORMED PERICARDIAL DRAINAGE. TO ICU AFTER PERICARDIAL DRAINAGE. (WE WILL CONFIRM THE SITUATION LATER AND REPORT IT). THE COMPLAINT PRODUCT(S) WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 10407333 ↗
• MalfunctionApr 9, 2020Leak/Splash; Leak/Splash

  MOBICATH SHEATH HAS SUCKED IN AIR DURING THE ASPIRATION PROCESS. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946867 ↗
• InjuryJul 17, 2019Malposition of Device; Malposition of Device

  DETAILED CIRCUMSTANCES AT THE TIME OF OCCURRENCE (ALWAYS STATED IF AN ERROR CODE IS KNOWN): WHEN THE WIRE AND THE CATHETER WERE INSERTED INTO THE LA, THE BLOOD PRESSURE DROPPED. WHEN IT WAS CONFIRMED ON ECHOCARDIOGRAPHY,DRAINAGE WAS PERFORMED BECAUSE PERICARDIAL FLUID HAD ACCUMULATED. ABLATION STOPPED. TIMING WHEN COMPLAINT OCCURRED: AFTER BB, WHEN THE CATHETER WAS APPROACHED TO THE LA. HOW THE PROCEDURE WAS COMPLETED: THE PROCEDURE WAS STOPPED. AFTER DRAINAGE WAS CONDUCTED, THE BLOOD PRESSURE WAS STABLE, WHEN THE PATIENT LEFT, THEIR CONDITION WAS STABLE. THE PHYSICIAN COMMENTED THAT, AFTER BB, WIRE AND THE CATHETER APPROACH, IT WAS LIKELY THAT THE WIRE (OR CATHETER) WERE INSERTED STRONGLY IN THE DIRECTION OF THE LEFT ATRIAL APPENDAGE, WHICH MIGHT BE THE CAUSE.

  Patient problems: Cardiac Tamponade

  MAUDE report 8800333 ↗
• MalfunctionJul 11, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SIDE PORT OF THE SHEATH FELL OFF. THE SHEATH WAS REPLACED AND THE CASE CONTINUED WITHOUT PATIENT CONSEQUENCES. THE CALLER IS REQUESTING A REPLACEMENT SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780800 ↗
• MalfunctionJan 11, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MOBICATH DEFLECTABLE SHEATH WAS NOTED TO BE ""LEAKING AT THE HEMO-STATIC VALVE"" WHEN IN USE FOR A PROCEDURE. THE PHYSICIAN EXCHANGED OUT FOR A NON-BWI SHEATH. CASE COMPLETED WITHOUT PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8239742 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN AFIB CASE, A PERICARDIAL EFFUSION WAS CONFIRMED AND FOUND THROUGH INTRACARDIAC ICE. CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS AND 200 CC'S WERE REMOVED. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 7859862 ↗
• MalfunctionJan 30, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING FROM THE HUB SHORTLY AFTER THE MOBI-CATH WAS INSERTED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7228917 ↗