Attain Select II + SureValveRecalls & reported problems across all models
Medtronic, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 146
- Deaths reported
- 2
- Injuries reported
- 13
- Recalls
- 0
We found 15 models of Attain Select II + SureValve by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Jun 4, 2025 — classified as 2 deaths, 13 injuries, 131 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (49 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Attain Select II + SureValve problems
Device problems
- Detachment of Device or Device Component49
- Break48
- Material Integrity Problem38
- Material Fragmentation17
- Adverse Event Without Identified Device or Use Problem10
- Detachment Of Device Component9
- Mechanical Problem7
- Accessory Incompatible5
Patient problems
- No Known Impact Or Consequence To Patient71
- No Clinical Signs, Symptoms or Conditions52
- Pericardial Effusion10
- No Consequences Or Impact To Patient7
- No Patient Involvement3
- Perforation3
- Perforation of Vessels3
- Vascular Dissection3
Attain Select II + SureValve models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Select™ II + SureValve™ 6248V-90CATHETER, PERCUTANEOUS35 reports
- Attain Select™ II + SureValve™ 6248V-130CATHETER, PERCUTANEOUS29 reports
- Attain Select™ II + SureValve™ 6248V-130Catheter, percutaneous17 reports
- Attain Select™ II + SureValve™ 6248V-90Catheter, percutaneous1 death17 reports
- Attain Select™ II + SureValve™ 6248V-130PCATHETER, PERCUTANEOUS13 reports
- Attain Select™ II + SureValve™ 6248V-90PCATHETER, PERCUTANEOUS1 death8 reports
- Attain Select™ II + SureValve™ 6248V-90LCATHETER, PERCUTANEOUS7 reports
- Attain Select™ II + SureValve™ 6248V-90SCATHETER, PERCUTANEOUS5 reports
- Attain Select™ II + SureValve™ 6248V-130LCATHETER, PERCUTANEOUS3 reports
- Attain Select™ II + SureValve™ 6248V-90PCatheter, percutaneous3 reports
- Attain Select™ II + SureValve™ 6248V-90SPCATHETER, PERCUTANEOUS2 reports
- Attain Select™ II + SureValve™ 6248V-90LCatheter, percutaneous2 reports
- Attain Select™ II + SureValve™ 6248V-90SCatheter, percutaneous2 reports
- Attain Select™ II + SureValve™ 6248V-90SPCatheter, percutaneous2 reports
- Attain Select™ II + SureValve™ 6248V-130PCatheter, percutaneous1 report
Recent Attain Select II + SureValve adverse event reports
The 15 most recent reports across all models, 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 22144218 ↗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 ↗MalfunctionMay 2, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THERE WAS SLITTING DIFFICULTY OF THE CATHETER. THE SLITTER CAME OUT THE SIDE OF THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951286 ↗MalfunctionApr 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER SEPARATED WHILE SLITTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21883763 ↗InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ACCESSED THE PATIENT'S VEIN USING AN INNER CATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE GUIDEWIRE WENT TO AN UNEXPECTED LOCATION IN THE TARGET VEIN AND THE PHYSICIAN BELIEVED IT WAS A SUB-BRANCH INSIDE THE VEIN. A LEAD WAS THEN INTRODUCED AND DID NOT CAPTURE ON ANY VECTOR. WHEN THE PHYSICIAN WAS ¿FISHING¿ FOR A NEW BRANCH TO PLACE THE LEAD, THEY NOTICED THAT THE WIRE WAS NOT IN THE SAME VEIN. THE PHYSICIAN THEN ELECTED TO DO A PUFF OF CONTRACT AND SAW THE CONTRACT DIFFUSE. THE INNER CATHETER WAS REMOVED AND IT WAS OBSERVED THAT THE PATIENT¿S BLOOD PRESSURE HAD DROPPED AND THE PHYSICIAN DID AN EMERGENCY PERICARDIOCENTESIS WHICH WAS SUCCESSFUL. IT WAS NOTED THAT THE PHYSICIAN SUSPECTED THAT THE INNER CATHETER WAS THE CAUSE OF THE PERICARDIAL EFFUSION AND A PERFORATION WAS ALSO OBSERVED. THE OPERATION WAS THEN ABORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation; Pericardial Effusion
MAUDE report 21587401 ↗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 21145525 ↗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 12, 2024Break; Break
IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE WHOLE LUER HUB DETACHED FROM THE CATHETER WHILE TRYING TO SLIT. THE PHYSICIAN WAS ABLE TO SUCCESSFUL SLIT BY USING A HEMOSTAT TO HOLD THE SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20435207 ↗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 ↗MalfunctionOct 6, 2024Detachment 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, THE PHYSICIAN TRIED TO SLIT THE CATHETER. THE CATHETER BODY COMPLETELY BROKE IN TWO PIECES NEAR THE LUER HUB. THE PHYSICIAN WAS ABLE TO CUT DOWN ON THE BODY AND SLIT. THE LEAD STAYED IN PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20380223 ↗MalfunctionJul 22, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED BY THE PHYSICIAN THAT DURING THE IMPLANT PROCEDURE, THE SLITTER WOULD NOT PROPERLY SLIT. IT WAS ¿JUST SHAVING THE SHEATH¿ AND NOT CUTTING/SLITTING THE DELIVERY CATHETER SHEATHS. THE PHYSICIAN REPLACED THE SLITTER AND WAS ABLE TO SLIT THE DELIVERY CATHETER SHEATHS WITHOUT ISSUE. THE DELIVERY 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 19802362 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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