Attain Select™ II + SureValve™ 6248V-130 (UDI 00643169143203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169143203), received between Feb 9, 2017 and Nov 23, 2021 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT DURING IMPLANT TWO CATHETERS BROKE WHILE SLITTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860828 ↗
• MalfunctionOct 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE AND AFTER THE HUB OF THE DELIVERY CATHETER WAS SLIT, THE CATHETER RIPPED OFF COMPLETELY ABOUT FIVE TO SEVEN CENTIMETERS DOWN LEAVING THE REMAINDER AROUND THE LEAD. THE PHYSICIAN WAS ABLE TO SLICE THE CATHETER AND REAPPLY THE SLITTER AND THE CATHETER WAS REMOVED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698057 ↗
• MalfunctionJun 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DELIVERY CATHETER PULLED APART INTO TWO PIECES DURING SLITTING. A DIFFERENT CATHETER 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 11935161 ↗
• MalfunctionMay 20, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHEN THE PHYSICIAN WAS SLITTING THE INNER SHEATH OF THE CATHETER IT CRACKED AND FELL APART AND THE PHYSICIAN HAD TO SLIT THE REST OF THE SHEATH BY HAND USING A DIFFERENT TOOL. 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 11855209 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE A PIECE OF THE CATHETER BROKE OFF WHILE SLITTING AND ENDED UP INSIDE THE BODY AND HAD TO BE SNARED TO REMOVE IT FROM THE VESSEL. IT WAS ALSO REPORTED THAT ANOTHER CATHETER BROKE OFF WHILE SLITTING AND HAD TO BE PULLED WITH HEMOSTATS AND SLIT AT THE SAME TIME TO REMOVE THE LEAD FROM THE CATHETER. THE CATHETER'S WERE SUCCESSFULLY REMOVED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716992 ↗
• MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHILE REMOVING THE CATHETER THE BLADE GOT OFF TRACK AND CUT OFF THE HANDLE PORTION OF THE CATHETER. THE PHYSICIAN HAD TO CREATE HIS OWN TAB TO ATTACH THE SLITTER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254452 ↗
• MalfunctionDec 2, 2020Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, WHILE SLITTING THE CATHETER, THERE WAS AN ISSUE SLITTING AND THE CATHETER COMPLETELY BROKE IN HALF. THE SECTIONS WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF ANOTHER CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931287 ↗
• InjuryOct 5, 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 CORONARY SINUS WAS DISSECTED WHEN THE CATHETER WAS BEING USED. IT WAS NOTED THAT THE CATHETER HAD "JUMPED" FORWARD AND EFFUSION WAS OBSERVED. A PERICARDIOCENTESIS WAS PERFORMED, BLOOD WAS TAKEN OUT OF THE PERICARDIAL SPACE, AND THE PROCEDURE WAS ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 10626989 ↗
• MalfunctionFeb 5, 2020Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN COULD NOT SLIT THE INNER SHEATH OF THE CATHETER BECAUSE THE HUB WAS TOO BIG AND IT BROKE APART. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9671125 ↗
• MalfunctionDec 20, 2019Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING THE LEFT VENTRICULAR (LV) LEAD IMPLANT PROCEDURE, THE LEAD "CAME BACK" AFTER TROUBLE DURING CATHETER SLITTING. THE LV LEAD WAS REMOVED AND, REPLACED WITH A DIFFERENT LV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9503849 ↗
• MalfunctionDec 19, 2019Detachment 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, AS THE PHYSICIAN WAS SLITTING THE DELIVERY CATHETER, THE TOP HANDLE BROKE. THE PHYSICIAN HAD TO FIND ANOTHER WAY TO CUT THE CATHETER. THE PHYSICIAN COMMENTED THE TOP PART OF THE CATHETER IS TOO HARD AND THAT RESULTED IN THE INABILITY TO SLIT ALL THE WAY THROUGH THE CATHETER. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497016 ↗
• MalfunctionDec 17, 2019Detachment 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, WHILE SLITTING THE CATHETER, THE CATHETER BROKE APPROXIMATELY 15 CENTIMETERS DISTAL OF THE VALVE. IT WAS ALSO REPORTED THAT WITH THE PROXIMAL END OF THE CATHETER SEPARATED THERE WAS NOTHING TO PULL ON TO PERFORM SLITTING. THE PHYSICIAN WAS ABLE TO GRAB THE CATHETER WITH A SURGICAL IMPLEMENT AND RE-ENGAGE THE CATHETER WITH THE SLITTER AND SLIT SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9482265 ↗
• MalfunctionOct 29, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THERE WAS DIFFICULTY SLITTING THE DELIVERY CATHETER. A DIFFERENT DELIVERY CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250604 ↗
• MalfunctionAug 14, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE A COUPLE OF INCHES PAST THE HUB DURING SLITTING AFTER THE LEAD WAS PLACED. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8892506 ↗
• MalfunctionAug 9, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE A COUPLE OF INCHES PAST THE HUB DURING SLITTING AFTER THE LEAD WAS PLACED. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879942 ↗
• MalfunctionJul 15, 2019Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE UPON SLITTING THE LEFT VENTRICULAR DELIVERY CATHETER THE PROXIMAL END OF THE CATHETER BROKE OFF. THE DISTAL PIECE WAS THEN HELD WITH A HEMOSTAT AND RIGHT ANGLE IRIS SCISSORS WERE THEN USED TO START A NEW SLIT SO THE REMAINING CATHETER COULD BE SLIT TO THE DISTAL TIP AND THE ENTIRE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8789670 ↗
• MalfunctionJun 3, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE CATHETER SPIRALED OFF AND BROKE DURING THE SLITTING PROCESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8664522 ↗
• MalfunctionJun 19, 2018Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CATHETER BROKE MIDWAY DOWN AND COMPLETELY (360 DEGREES AROUND.) THE CATHETER WAS CUT WITH SCISSORS. A SECOND CATHETER WAS TRIED, BUT THE SAME ISSUE OCCURRED AND ADDITIONALLY THE DEFLECTABLE WIRE CAME OUT WHILE THE CATHETER WAS BEING SLIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7616077 ↗
• MalfunctionApr 25, 2018Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE SLITTING, THE CATHETER BROKE ABOUT 6 INCHES FROM HUB. THE DOCTOR HAD TO MANUALLY SLIT ANOTHER OPENING TO FINISH SLITTING THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7461301 ↗
• MalfunctionApr 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE DELIVERY CATHETER BROKE IN TWO WHILE SLITTING. THE PHYSICIAN WAS ABLE TO RE-ENGAGE THE REMAINING CATHETER AND FINISH SLITTING. NO FURTHER ACTION 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 7460570 ↗
• MalfunctionFeb 8, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED THAT WHEN OPENING THE PLASTIC PACKAGING OF THE CATHETER DURING IMPLANT, THE PLASTIC HAD GONE OFF THE TRACK, OPENED AT A SLANT AND CREATED A SMALL HOLE THAT PULLED THE STERILE INSIDES FROM THE PACKAGING. THE CATHETER WAS NOT USED. NO PATIENT INVOLVEMENT HAS BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7256195 ↗
• MalfunctionFeb 8, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE GUIDE CATHETER CUT IN HALF DURING SHEATH SLITTING. THE CATHETER WAS REMOVED AND A DIFFERENT CATHETER WAS USED TO COMPLETE THE LEAD IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7255437 ↗
• MalfunctionDec 7, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE APART APPROXIMATELY TWO INCHES FROM THE HUB DURING THE SLITTING PROCESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7092666 ↗
• MalfunctionDec 7, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DELIVERY CATHETER BROKE IN HALF WHILE SLITTING. THE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7092086 ↗
• MalfunctionOct 6, 2017Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN WAS SLITTING THE INNER CATHETER, PART OF THE CATHETER SPLIT OFF FROM THE REST OF THE CATHETER. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6923008 ↗