ATTAIN COMMAND™ 6250C02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994334831), received between Jun 8, 2017 and Apr 25, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE AS THE CORONARY SINUS WAS BEING ENTERED BY THE CATHETER AND CONTRAST GIVEN, THE PATIENT EXPERIENCED A MILD PERICARDIAL TAMPONADE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS REPORTED TO BE RECOVERED THE FOLLOWING DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 7459994 ↗
• MalfunctionFeb 8, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AND PRIOR TO INSERTING THE BALLOON CATHETER INTO THE VASCULATURE, THE BALLOON OF THE CATHETER BURST. IN ADDITION, IT WAS NOTED A SEPARATE DELIVERY CATHETER LEAKED AFTER TIGHTENING THE VALVE. THE BALLOON CATHETER AND DELIVERY CATHETER WERE NOT UTILIZED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7255260 ↗
• MalfunctionAug 9, 2017Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DELIVERY CATHETERS LEAKED AND WERE NOT SMOOTH IN OPERATION. THE DELIVERY CATHETERS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783660 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HEART FAILURE AS THE CATHETER WAS BEING USED AND EMERGENCY RESCUE WAS DONE. THE PROCEDURE WILL BE RESCHEDULED WHEN THE PATIENT'S HEART FAILURE IS BETTER-CONTROLLED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure

  MAUDE report 6627159 ↗