Attain Select™ II + SureValve™ 6248V-90 (UDI 00643169143210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169143210), received between Apr 6, 2017 and Nov 2, 2023 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DISTAL TIP OF THE CATHETER BROKE IN THE PATIENT. A SNARE HAD TO BE USED TO GET THE TIP OF THE CATHETER OUT. ADDITIONALLY, IT WAS NOTED THAT THE CATHETER WAS EXPIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057113 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN WAS ATTEMPTING TO INSERT THE CATHETER INTO THE OUTER CATHETER. THE OUTSIDE LAYER CRUMBLED AND PEELED AWAY. THE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901680 ↗
• 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 11716993 ↗
• MalfunctionApr 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DELIVERY CATHETER BROKE NEAR THE DISTAL END WHILE SLITTING. THE REMAINING PORTION WAS REMOVED BY USING IRIS SCISSORS TO CUT THE REMAINING SEGMENT. NO OTHER ISSUES WERE NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702294 ↗
• InjuryMar 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COMPETITOR IMPLANT PROCEDURE WHILE ADVANCING A GUIDEWIRE, THE TIP OF THE CATHETER DILATOR BROKE OFF AND LODGED IN THE RIGHT ATRIUM. THE PATIENT UNDERWENT ADDITIONAL INTERVENTION TO SNARE THE TIP AND IT WAS SUCCESSFULLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11430143 ↗
• MalfunctionNov 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INNER CATHETER BROKE INTO THREE PIECES. THE CATHETER WAS NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10801029 ↗
• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE CATHETER BROKE WHILE BEING SLIT. THE CATHETER WAS REMOVED, AND THE LV LEAD WAS CHECKED AND ALL MEASUREMENTS WERE WITHIN A NORMAL RANGE. THE DAY AFTER THE IMPLANT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH, UNDEFINED IMPEDANCES AND LOSS OF CAPTURE. THE POCKET WAS OPENED AND IT WAS NOTED THE LV LEAD WAS FRACTURED IN TWO PIECES. THE LV LEAD WAS EXPLANTED. A REPLACEMENT LV LEAD IMPLANT WAS ATTEMPTED, BUT THE LEAD COULD NOT BE DELIVERED TO A STABLE AREA. THE REPLACEMENT LV LEAD WAS REMOVED AND THE PATIENT WAS LATER IMPLANTED WITH AN EPICARDIAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10531493 ↗
• MalfunctionSep 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE IN HALF DURING THE SLITTING PROCESS CAUSING THE LEFT VENTRICULAR (LV) LEAD TO DISLODGE. IT WAS NOTED UPON DISLODGING, THE LEAD GRABBED THE LOOSE END OF THE CATHETER AND BROUGHT IT OUT OF THE BODY. THE LV LEAD WAS SUCCESSFULLY PLACED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10505576 ↗
• MalfunctionMay 27, 2020Break; Break

  IT WAS REPORTED THAT DURING SLITTING, THE PHYSICIAN ENCOUNTERED DIFFICULTY CUTTING THROUGH THE HUB. ONCE THROUGH THE HUB, THE INNER CATHETER BROKE IN HALF AND THE REMAINING INNER PORTION WAS LEFT ON THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092982 ↗
• MalfunctionDec 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PROXIMAL PORTION OF THE DELIVERY CATHETER DETACHED FROM THE CATHETER BODY WHILE SLITTING. THE PHYSICIAN MANUALLY CUT THE SHEATH USING A SCISSOR TO RE-ENGAGE ENOUGH MATERIAL TO GRIP AND CONTINUE SLITTING. THE DELIVERY 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 9399814 ↗
• MalfunctionNov 25, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HEMOSTATIC VALVE WAS DIFFICULT TO CUT. IT WAS NOTED THE SLITTER USED TO SLIT THE SHEATH DID NOT CUT THE CATHETER. THE PHYSICIAN UTILIZED SCISSORS AND HEMOSTATS TO REMOVE THE ADHESIVE SECTION OF THE VALVE. 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 9373690 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE BACK HUB OF THE CATHETER BROKE WHILE BEING SLIT. A DIFFERENT CATHETER WAS USED TO COMPLETE THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9370306 ↗
• MalfunctionJul 25, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CATHETER SPLIT IN HALF ABOUT FOUR INCHES FROM THE VALVE AS THE PHYSICIAN WAS SLITTING IT, AND THEN THE REMAINING PORTION COULD NOT BE SPLIT. 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 8827483 ↗
• MalfunctionJul 15, 2019Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CATHETER BROKE IN HALF WHILE IT 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 8789463 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HANDLE BROKE OFF THE CATHETER DURING SLITTING. 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 8735904 ↗
• MalfunctionMay 15, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE DELIVERY CATHETER SHEATH BROKE IN HALF WHILE SLITTING DURING AN IMPLANT PROCEDURE. CUTTING OF THE SHEATH WAS FINISHED USING SCISSORS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8613253 ↗
• MalfunctionMar 21, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LEUR HUB BROKE OFF THE CATHETER DURING SLITTING. THE HUB AND CATHETER WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8440454 ↗
• MalfunctionMar 18, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PROXIMAL TWO INCHES OF THE DELIVERY CATHETER SEPARATED FROM THE DISTAL PART OF THE SHEATH WHILE SLITTING. THE CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8430627 ↗
• MalfunctionMar 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PROXIMAL END OF THE SHEATH SEPARATED FROM THE DISTAL END WHILE SLITTING THE DELIVERY CATHETER. THE DELIVERY CATHETER WAS REPLACED AND A NEW DELIVERY CATHETER WAS USED TO COMPLETE THE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8426546 ↗
• MalfunctionMar 11, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD DIFFICULTY SLITTING THE CATHETER WITH TWO SEPARATE SLITTERS. THE PHYSICIAN STATED THAT THE HUB FELT DIFFERENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408290 ↗
• MalfunctionFeb 8, 2019Accessory Incompatible; Break; Accessory Incompatible; Break

  IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, WHEN THE PHYSICIAN WAS SLITTING THE SHEATH, THE SLITTER DISENGAGED FROM THE DELIVERY SHEATH AND COULD NOT BE EASILY REENGAGED. REPEATED ATTEMPTS TO REENGAGE THE SLITTER RESULTED IN THE CATHETER "BREAKING". A CUT HAD TO BE MADE WITH AN IRIS SCISSORS IN THE CATHETER TO PROVIDE ENTRY FOR THE SLITTER BLADE. THE PHYSICIAN WAS THEN ABLE TO CONTINUE SLITTING, BUT WITH DIFFICULTY. THE SHEATH WAS EVENTUALLY SLIT, BUT IN THE PROCESS THE LEFT VENTRICULAR LEAD DISLODGED AND WAS TRAPPED INSIDE THE CATHETER. THE CATHETER AND LEAD WERE REMOVED. THE DECISION WAS MADE TO ABANDON THE LEAD AS POSSIBLE DAMAGE TO THE LEAD DURING THE SLITTING PROCESS COULD NOT BE RULED OUT. A NEW LEAD WAS SUBSEQUENTLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8320930 ↗
• MalfunctionJan 18, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CATHETER FOR THE LEFT VENTRICULAR (LV) LEAD WAS DIFFICULT TO SLIT AND THE PROXIMAL PORTION BROKE OFF. THE CATHETER AND REMAINING TIP WERE REMOVED FROM THE PATIENT. DURING THAT TIME, A COMPETITOR GUIDEWIRE WAS LEFT IN THE LV LEAD AND IT WAS THEN DIFFICULT TO REMOVE. THE LEAD TESTED NORMALLY AND FLUOROSCOPY REVEALED NO EVIDENCE OF DAMAGE; THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8261827 ↗
• MalfunctionJan 10, 2019Material Fragmentation; Detachment of Device or Device Component; Material Integrity Problem; Material Fragmentation; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE IN HALF WHILE THE PHYSICIAN WAS SLITTING THE CATHETER. IT WAS NOTED THAT THE PHYSICIAN REMOVED THE OUTER CATHETER WITH HEMOSTATS AND CONTINUED TO SLIT THE LEAD WITH GREAT DIFFICULTY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8235813 ↗
• MalfunctionNov 14, 2018Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SHEATH BROKE IN HALF DURING THE SLITTING, WHICH CAUSED THE LEFT VENTRICULAR (LV) LEAD TO BE PULLED OUT. THE PHYSICIAN HAD TO RESTART THE CORONARY SINUS ACCESS FROM THE BEGINNING. THE LEAD WAS ULTIMATELY PLACED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8069630 ↗
• 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 8056178 ↗