Attain Select™ II + SureValve™ 6248V-130LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169143173), received between Oct 10, 2017 and Jun 25, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2019Accessory Incompatible; Deformation Due to Compressive Stress; Accessory Incompatible; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE CATHETER HAD DIFFICULTY SLITTING, WAS OBSERVED TO BE KINKED, AND THE LEFT VENTRICULAR (LV) LEAD DISLODGED DURING THIS PROCESS. THE LV LEAD WAS REPOSITIONED AND WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731655 ↗
• MalfunctionNov 9, 2018Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE TWO CATHETERS BROKE IN THE SAME SPOT DURING SLITTING. IT WAS NOTED THE LEFT VENTRICULAR (LV) LEAD DID NOT STAY IN PLACE BECAUSE THE INNER CATHETERS KEPT BREAKING DURING SLITTING. THE LEAD WAS ATTEMPTED AND NOT USED. THE DOCTOR DECIDED TO INSTALL A DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INSTEAD OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8056155 ↗
• 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 6937131 ↗