Attain Select™ II + SureValve™ 6248V-130 (UDI 00763000160517)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000160517), received between Oct 8, 2021 and Jun 4, 2025 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Accessory Incompatible; Break; Mechanical Problem; Material Integrity Problem; Accessory Incompatible; Break; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A FEW DIFFERENT CATHETERS WERE USED AS THERE WAS SLITTING DIFFICULTY THAT CAUSED THE LEFT VENTRICULAR (LV) LEAD TO DISLODGE. IT WAS NOTED THAT THE CATHETERS KEPT BREAKING AND THAT THE VALVES WERE VERY DIFFICULT TO PASS THROUGH. ONE OF THE CATHETERS BECAME STUCK IN THE VALVE DURING THE LEAD IMPLANT. A DIFFERENT LV LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144210 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER HUB SNAPPED. IT WAS NOTED THAT WHEN THE PHYSICIAN WENT TO SLIT, MINIMAL PRESSURE WAS PUT ON THE CATHETER AND THE VALVE COMPLETELY CRACKED OFF FROM THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038458 ↗
• MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL END OF THE DELIVERY CATHETER BROKE OFF APPROXIMATELY FOUR INCHES FROM THE TIP DURING SLITTING. DIFFERENT PRODUCT WAS USED TO COMPLETE THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168432 ↗
• MalfunctionJan 13, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LEFT VENTRICULAR (LV) LEAD IMPLANT TWO DIFFERENT CATHETERS WERE USED. DURING THE FIRST ATTEMPT IT WAS NOTED THAT WHEN THE PHYSICIAN WENT TO SLIT THE CATHETER, THE HANDLE OF THE HUB BROKE OFF, PULLING THE CATHETER THROUGH THE SLITTER AND CAUSING THE SLITTER TO COME OFF THE RAIL THUS CAUSING THE LEAD TO GET TRAPPED IN THE CATHETER AND DISLODGING THE LEAD. DURING THE SECOND ATTEMPT IT WAS NOTED THAT THE HUB CATHETER BROKE OFF AGAIN NEARLY DISLODGING THE LEAD AGAIN HOWEVER THE LEAD WAS SUCCESSFULLY IMPLANTED. THE CATHETERS WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145524 ↗
• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER BODY DETACHED FROM THE HUB. THE CATHETER WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561822 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THAT DURING USE OF THE DELIVERY CATHETER, THE LUER HUB DETACHED, BROKE OFF THE CATHETER WHILE STARTING THE SLITTING PROCESS. NO ACTION WAS TAKEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20387842 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CORONARY SINUS WAS ACCESSED WITH TWO DELIVERY CATHETERS AND THERE WAS AN ATTEMPT TO PLACE A LEFT VENTRICULAR (LV) LEAD IN SEVERAL DIFFERENT BRANCHES WITH NO SUCCESS. IT WAS NOTED THAT THERE WAS INTERMITTENT CAPTURE AT HIGH OUTPUTS. IT WAS DECIDED TO DO AN OCCLUDED VENOGRAM FLUOROSCOPY SAVE. THE LV LEAD WAS PLACED IN TWO OTHER BRANCHES AS WELL AND THERE WAS NO CAPTURE. THE DECISION WAS MADE TO ABORT THE CASE AS THE PATIENT¿S BLOOD PRESSURE WAS GETTING LOW AND THERE WERE NO BRANCHES THAT WERE USABLE. THE TWO DELIVERY CATHETERS AND LV LEAD WERE REMOVED FROM THE PATIENT. THE PATIENT THEN COMPLAINED OF DIFFICULTY BREATHING. THE PHYSICIAN CALLED FOR AN ULTRASOUND MACHINE AND THEN A CODE. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED WITH NO COMPLICATIONS. IT WAS NOTED THAT THE EXISTING LEADS WERE NEVER DISCONNECTED, AND THE EXISTING IMPLANTABLE PULSE GENERATOR (IPG) PACING MODE WAS CHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Pericardial Effusion

  MAUDE report 19282811 ↗
• MalfunctionApr 5, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER SUB-SELECTOR HUB BROKE WHILE THE PHYSICIAN WAS SLITTING WITH A COMPETITOR SLITTER. THE SLITTING WAS COMPLETED WITHOUT INTERVENTION AND THE CATHETER WAS DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052616 ↗
• InjuryNov 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE USING THE CATHETER, A PERFORATION OF THE CORONARY SINUS AND PERICARDIAL EFFUSION OCCURRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 18132738 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER APPROXIMATELY FOUR TO FIVE INCHES OF SLITTING OF THE INNER CATHETER, THE CATHETER SEPARATED IN A CROSS SECTION FASHION. IT WAS DESCRIBED AS SEPARATING LIKE A PEN CAP COMING OFF OF A PEN. THE PHYSICIAN CUT THE REST OF THE INNER CATHETER WITH A SURGICAL SCISSORS AND REMOVED IT SUCCESSFULLY FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477095 ↗
• MalfunctionJun 2, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY SLITTING THE DELIVERY CATHETER AND THE CATHETER WAS DIFFICULT TO RE-ENGAGE AFTER IT SLICED APART. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052013 ↗
• MalfunctionApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHEN SLITTING THE SUBSELECTOR AFTER LEAD PLACEMENT, THE HUB BROKE OFF IN ONE PIECE WHERE THE HUB ATTACHES TO THE CATHETER. THE PHYSICIAN WAS UNABLE TO REENGAGE THE ADJUSTABLE SLITTER TO SLIT THE REMAINDER OF THE SUBSELECTOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761117 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HUB OF THE CATHETER CAME OFF WHILE SLITTING. AS A RESULT, THE LEFT VENTRICULAR (LV) LEAD HAD TO BE EXPLANTED AND THE PHYSICIAN WAS UNSUCCESSFUL IN REIMPLANTING IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699616 ↗
• InjuryOct 20, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHILE TRYING TO CANNULATE THE LATERAL VENTRICULAR VEIN WITH THE CATHETER THE LEFT V ENTRICULAR (LV) LEAD SUDDENLY POPPED ACROSS THE PERCEIVED LOCATION OF THE CORONARY SINUS. A CONTRAST INJECTION SHOWED GROSSLY FILLING THE PERICARDIAL SACK. A PERICARDIAL TAMPONADE WAS OBSERVED LEADING TO A SUDDEN DECREASE IN ARTERIAL LINE PRESSURE REQUIRING PERI CARDIOCENTESIS DRAIN. THE LEAD PLACEMENT WAS ABANDONED AND THE LEAD AND CATHETER WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 15640586 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT WHEN THE CATHETER TOUCHED SALINE DURING PREPARATION FOR USE, THE COATING AT THE DISTAL END TURNED A STRANGE COLOR, BECAME GRAINY AND STARTED TO DISINTEGRATE. NO ATTEMPT WAS MADE TO USE THE CATHETER. A SECOND CATHETER WAS SELECTED FOR THE PROCEDURE AND DID NOT HAVE THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062294 ↗
• MalfunctionOct 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN SLITTING, THE CATHETER BROKE INTO SEVERAL PIECES ABOUT TEN CENTIMETERS DOWN FROM THE PORT. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623728 ↗
• MalfunctionOct 8, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN CUTTING THE DELIVERY CATHETER WITH THE COMPETITOR SLITTER, THE PHYSICIAN NOTED THAT IT WAS GOING WELL UNTIL THE CATHETER WAS COMPLETELY SEVERED AND WERE UNABLE TO RESTART THE SLIT. THE LEAD AND DISTAL END OF THE CATHETER WERE REMOVED AND A NEW CATHETER WAS USED TO SUCCESSFULLY IMPLANT THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601654 ↗