Attain Command + SureValveRecalls & reported problems across all models
Medtronic, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 5
- Injuries reported
- 23
- Recalls
- 0
We found 17 models of Attain Command + SureValve by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Mar 23, 2026 — classified as 5 deaths, 23 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (11 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 Command + SureValve problems
Device problems
- Adverse Event Without Identified Device or Use Problem26
- Material Integrity Problem11
- Break4
- Accessory Incompatible3
- Mechanical Problem2
- Activation, Positioning or Separation Problem1
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
Patient problems
- Vascular Dissection12
- No Clinical Signs, Symptoms or Conditions11
- Pericardial Effusion11
- Perforation6
- No Known Impact Or Consequence To Patient5
- Cardiac Tamponade4
- Perforation of Vessels4
- Cardiac Arrest3
Attain Command + SureValve models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Command™ + SureValve™ 6250V-MPCatheter, percutaneous1 death9 reports
- Attain Command™ + SureValve™ 6250V-EHCATHETER, PERCUTANEOUS1 death8 reports
- Attain Command™ + SureValve™ 6250V-EHCatheter, percutaneous6 reports
- Attain Command™ + SureValve™ 6250V-MPCATHETER, PERCUTANEOUS1 death3 reports
- Attain Command™ + SureValve™ 6250V-MPXCATHETER, PERCUTANEOUS2 reports
- Attain Command™ + SureValve™ 6250V-EHXLCATHETER, PERCUTANEOUS2 reports
- Attain Command™ + SureValve™ 6250VCCATHETER, PERCUTANEOUS2 reports
- Attain Command™ + SureValve™ 6250V-MB2XCatheter, percutaneous2 reports
- Attain Command™ + SureValve™ 6250V-3DCATHETER, PERCUTANEOUS1 report
- Attain Command™ + SureValve™ 6250V-45SCATHETER, PERCUTANEOUS1 report
- Attain Command™ + SureValve™ 6250V-45SCatheter, percutaneous1 report
- Attain Command™ + SureValve™ 6250V-EHXLCatheter, percutaneous1 report
- Attain Command™ + SureValve™ 6250V-MB2Catheter, percutaneous1 report
- Attain Command™ + SureValve™ 6250V-MPXCatheter, percutaneous1 report
- Attain Command™ + SureValve™ 6250V-MPRCatheter, percutaneous1 report
- Attain Command™ + SureValve™ 6250VCCatheter, percutaneous1 death1 report
- Attain Command™ + SureValve™ 6250VSCatheter, percutaneous1 death1 report
Recent Attain Command + SureValve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Break
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HUB OF THE CATHETER PARTIALLY DETACHED FROM THE CATHETER WHILE SLITTING. THE PHYSICIAN EXPRESSED CONCERN THAT THE HUB WOULD COMPLETELY DETACH, MAKING SLITTING VIRTUALLY IMPOSSIBLE. THE PHYSICIAN NOTED THAT THIS HAS BEEN AN ISSUE MORE RECENTLY. THE CATHETER WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664132 ↗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 22144206 ↗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 22144041 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A PERFORATION OCCURRED WHILE THE CATHETER WAS BEING USED TO GAIN ACCESS TO THE CORONARY SINUS. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND THE CATHETER WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation of Vessels
MAUDE report 21596210 ↗MalfunctionNov 6, 2024Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT DURING USE OF THE DELIVERY, THE PRODUCT WAS NOTED TO BE EXPIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20623250 ↗DeathJul 24, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS FURTHER CONFIRMED IN FOLLOW UP THAT THE CAUSE OF DEATH WAS NOT RELATED TO ANY LEAD PERFORMANCE OR PATIENT HISTORY OF DISEASE OR PATIENT CONDITION.
Patient problems: Bradycardia; Cardiac Arrest; Cardiac Tamponade; Hypoxia; Low Blood Pressure/ Hypotension; Pericardial Effusion; Syncope/Fainting
MAUDE report 19816770 ↗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 19801834 ↗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 19282809 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, GUIDEWIRE WIRES BECAME UNRAVELED. IT WAS ALSO REPORTED THAT DURING USE OF THE DELIVERY CATHETER VEIN DISSECTION OBSERVED WITH CONTRAST INJECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Vascular Dissection
MAUDE report 18974127 ↗MalfunctionDec 14, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO SLIT THE SHEATH, AND WHILE SLITTING, IT APPEARED THAT THE HUB WAS GOING TO FALL OFF. THE IMPLANT PROCEDURE WAS COMPLETED WITHOUT USING A SEPARATE SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18325658 ↗InjurySep 29, 2023Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN COULD NOT SLIT THROUGH THE HUB 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 17843483 ↗DeathJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED DURING THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM IMPLANT. A SMALL EFFUSION HAD BEEN NOTED VIA ECHOCARDIOGRAM PRIOR TO THE PROCEDURE. THE EFFUSION WAS NOTED TO BE LARGER, THOUGH STILL INSIGNIFICANT, DURING THE IMPLANT. THE PATIENT EXPIRED DUE TO HYPOXIC RESPIRATORY FAILURE NINE DAYS LATER, THOUGH THE DEATH WAS REPORTEDLY UNRELATED TO THE SYSTEM.
Patient problems: Hypoxia; Pericardial Effusion; Respiratory Failure
MAUDE report 16218371 ↗MalfunctionJan 12, 2023Accessory Incompatible; Accessory Incompatible
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SIGNIFICANT FALL EVENT AND THE LEFT VENTRICULAR (LV) LEAD WAS SUSPECTED TO HAVE LEAD PARTIALLY DISLODGED AS A RESULT OF THE FALL. EVALUATION REVEALED THE LV LEAD WAS FOUND TO BE IN THE TARGET VESSEL BUT HAD RETRACTEDFROM THE INITIAL POSITION DISTAL IN THE VESSEL. AS A RESULT OF THE LEAD RETRACTION, THE THRESHOLD INCREASED TO HIGH OUTPUTS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LONGEVITY DROPPED TO LESS THAN TWO YEARS. A LV LEAD REVISION WAS SCHEDULED. DURING THE LV LEAD REVISION AN UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE THE LV LEAD OVER A STYLET. A GUIDE CATHETER WAS PLACED AND THE LV LEAD WAS PLACED DISTAL, SECURED IN THE TARGET VESSEL AND LEAD SECURITY WAS TESTED. THE LV LEAD THRESHOLD TESTING WAS PERFORMED AND FOUND TO BE ACCEPTABLE. DURING THE GUIDE CATHETER REMOVAL AND SLITTING THE LV LEAD DISLODGED. THE LV LEAD WAS EXPLANTED AND THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16147659 ↗DeathAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD AND USE OF THE CATHETER, IT WAS OBSERVED THAT THE GUIDEWIRE AND THE LEAD WERE ADVANCING DOWN A NON-VISUALIZED PATH ON THE VENOGRAM. A CORONARY SINUS DISSECTION HAD OCCURRED, THE PATIENT'S BLOOD PRESSURE WAS LOW, AND A CODE WAS CALLED. THE LEAD, THE CATHETER, THE SHEATH AND THE GUIDEWIRE WERE REMOVED IMMEDIATELY. PERICARDIAL EFFUSION AND TAMPONADE FROM THE PERFORATION WERE OBSERVED. PULSELESS ELECTRICAL ACTIVITY (PEA) WAS DIAGNOSED AND RESCUE ATTEMPTS WERE PERFORMED. THE PHYSICIAN PERFORMED A STERNOTOMY TO EVACUATE THE CAVITY AND REPAIR HEART. BLOOD AND FLUID WAS SUCCESSFULLY REMOVED TO RELIEVE TAMPONADE AND THE TEAR WAS SURGICALLY REPAIRED. THE PATIENT WAS GIVEN FOUR UNITS OF BLOOD. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND PASSED AWAY.
Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion; Vascular Dissection
MAUDE report 15212274 ↗InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PERFORATION OF THE CORONARY SINUS OCCURRED DURING ATTEMPTED LEFT VENTRICULAR (LV) LEAD IMPLANT. THE LEAD HAD BEEN PLACED AND THE DELIVERY CATHETER SLIT WITHOUT DIFFICULTY. IT WAS NOTED UNDER FLUOROSCOPY THAT THE LEAD HAD PULLED BACK SLIGHTLY. THE PHYSICIAN WAS PREPARING TO REPOSITION THE LEAD WHEN A DROP IN THE PATIENT'S BLOOD PRESSURE AND DETERIORATING VITALS WERE NOTED. THE LEAD AND CATHETER WERE REMOVED. THE PATIENT BECAME UNSTABLE AND CODED AND AN ECHOCARDIOGRAM CONFIRMED CARDIAC TAMPONADE. CARDIOPULMONARY RESUSCITATION WAS STARTED AND A PERICARDIAL THORACENTESIS WAS PERFORMED. THE PERFORATION REQUIRED OPENING OF THE CHEST, A BLOOD TRANSFUSION, AND SURGICAL REPAIR OF THE MID-CORONARY SINUS. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) IN AN INTUBATED BUT STABLE STATE. IT IS UNKNOWN IF THE LEAD OR THE CATHETER OR BOTH CAUSED THE PERFORATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Cardiac Tamponade; Perforation of Vessels
MAUDE report 15130426 ↗
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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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