Attain Select™ II + SureValve™ 6248V-90P (UDI 00643169184190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169184190), received between Oct 10, 2017 and Jun 16, 2021 — classified as 1 death, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionJun 16, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE CATHETER DID NOT SLIT PROPERLY. IT WAS NOTED, WHEN SLITTING THE INNER CATHETER, THE SLITTER LEFT ABOUT 10CM OF THE INNER CATHETER ON THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN WAS ABLE TO CUT OFF THE REMAINING INNER CATHETER TO REMOVE IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010014 ↗
• DeathOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS HAD BEEN PLACED AND THE PHYSICIAN WAS ATTEMPTING TO GAIN ACCESS TO THE CORONARY SINUS FOR THE LEFT VENTRICULAR (LV) LEAD IMPLANT WHEN THE PATIENT WENT INTO FLASH PULMONARY EDEMA. THE PATIENT'S BLOOD PRESSURE DROPPED ALONG WITH THE OXYGEN SATURATION. THE PATIENT CODED AND CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED FOR ABOUT ONE HOUR, HOWEVER, THE PATIENT DIED.

  Patient problems: Cardiac Arrest; Death; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pulmonary Edema

  MAUDE report 10766591 ↗
• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED THAT DURING SLITTING OF THE CATHETER THE PRODUCT COMPLETELY BROKE AND LEFT A LARGE PORTION OF THE CATHETER AROUND THE LEAD. THE HEALTHCARE PROFESSIONAL HAD TO USE A BLADE TO CUT OPEN THE REMAINING PORTION OF THE CATHETER, AND APPLY STRONG GRIP TO COMPLETE THE SLITTING PROCESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515503 ↗
• MalfunctionJul 1, 2020Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, UPON SLITTING, THE HEAD OF THE CATHETER BROKE OFF THREE CENTIMETERS FROM THE TOP. THE PHYSICIAN WAS UNABLE TO REMOVE THE CATHETER WITHOUT THE LEAD SO THE LEAD AND CATHETER WERE REMOVED TOGETHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217310 ↗
• MalfunctionFeb 25, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHILE THE PHYSICIAN WAS SLITTING THE GUIDE CATHETER WITH A COMPETITOR SLITTER, THE CATHETER BROKE IN HALF. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751877 ↗
• MalfunctionMay 11, 2018Detachment Of Device Component; Material Fragmentation; Detachment Of Device Component; Material Fragmentation

  IT WAS REPORTED THAT THE DELIVERY CATHETER BROKE IN TWO DURING SLITTING. THE BREAK OCCURRED OUTSIDE OF THE BODY AND NO INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7508781 ↗
• MalfunctionFeb 8, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING IMPLANT, THE CATHETER BROKE INTO TWO PIECES WHILE SLITTING. THE CATHETER WAS NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7256256 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT EXPERIENCED A PERFORATION. IT WAS NOTED DURING THE PROCEDURE, THE CORONARY SINUS WAS LOCATED AND A SHEATH WAS ADVANCED INTO THE CORONARY SINUS AND A BALLOON VENOGRAPHY LOCATED THE TARGET VESSEL. THE LATERAL TARGET VESSEL WAS CANNULATED WITH A SUBSELECTING CATHETER AND THEN A SECOND SUBSELECTING CATHETER WAS ADVANCED INTO THE TARGET BUT A VENOGRAPHY REVEALED THE DISTAL PERFORATION. ALL THE LEADS AND SHEATHS WERE REMOVED. A PERICARDIAL TAP WAS PERFORMED AND DRAINED. THE POCKET WAS CLOSED AND THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE. A SECOND PERICARDIAL TAP WAS PERFORMED AT A DIFFERENCE ANGULATION. ADDITIONAL DRAINAGE OCCURRED AND ULTIMATELY THE DRAINAGE STOPPED WITH A SMALL RESIDUAL EFFUSION AND THE PATIENT REMAINED STABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 6937137 ↗