EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS29Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690103194166), received between May 5, 2021 and Jun 17, 2026 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (P140031); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY IMPLANT PATIENT REGISTRY, THE PATIENT EXPIRED ON THE NIGHT OF THE OPEN VALVE-IN-MAC (MITRAL ANNULAR CALCIFICATION) PROCEDURE USING A 29 MM SAPIEN 3 ULTRA RESILIA VALVE. THE PATIENT ENDED UP HAVING A BLEED IN THE OPERATING ROOM THAT IMPLANTER ATTRIBUTED TO A LEFT VENTRICLE (LV) PERFORATION FROM THE WIRE. THE IMPLANTER FIXED THE PERFORATION, AND THE PATIENT WAS STABLE GOING UPSTAIRS AND LATER IN THE EVENING THE PATIENT'S CONDITION DETERIORATED RAPIDLY LEADING TO THEM OPENING THE CHEST AGAIN. ACCORDING TO THE IMPLANTER THERE WAS BRUISING ON THE HEART AND MORE BLEEDING THAT HE SUSPECTED WAS FROM BALLOONING/EXPANDING THE VALVE IN THE MITRAL CALCIUM. THEY WERE UNABLE TO STOP THE BLEEDING AND THE PATIENT EXPIRED. FOLLOW-UP INFORMATION FROM THE FIELD CLINICAL SPECIALIST (FCS) INDICATED THAT THE DELIVERY SYSTEM REMAINED OVER THE GUIDEWIRE AND WAS UTILIZED TO STABILIZE THE BALLOON, WITH THE INTENT OF PREVENTING THE NOSE CONE OF THE CERTITUDE SYSTEM FROM CONTACTING THE VENTRICULAR WALL. DESPITE THESE PRECAUTIONS, IT WAS REPORTED THAT THE GUIDEWIRE MAY HAVE RESULTED IN VENTRICULAR INJURY.

  Patient problems: Cardiac Perforation

  MAUDE report 25539681 ↗
• InjuryAug 5, 2025Unintended Movement; Unintended Movement

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAORTIC TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE VALVE EMBOLIZED DURING DEPLOYMENT. WHILE ADVANCING THE SAPIEN 3 VALVE THROUGH THE 21FR CERTITUDE SHEATH, THE TEAM NOTED THE VALVE SLIPPED BACK ON THE DELIVERY SYSTEM BALLOON. THE TEAM MADE THE DECISION TO PRECEDE WITH DEPLOYMENT, AND DURING DEPLOYING, THE VALVE SLIPPED BACK FURTHER ON THE BALLOON AND MOVED AORTIC. THE TEAM MADE A FEW ATTEMPTS TO RETRIEVE THE VALVE VIA THE TRANSAORTIC SITE WITHOUT SUCCESS. THEREFORE, THE DECISION WAS MADE TO OPEN THE AORTA AND PERFORM AN AORTIC VALVE REPLACEMENT WITH A 25MM INSPIRIS RESILIA VALVE. THE IMPLANT WAS SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723143 ↗
• InjuryMay 27, 2025Difficult or Delayed Positioning; Difficult to Remove; Device Slipped; Difficult or Delayed Positioning; Difficult to Remove; Device Slipped

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA CAROTID ACCESS, THE 29MM CERTITUDE DELIVERY SYSTEM WAS UNABLE TO CROSS THE HEAVILY CALCIFIED AORTIC VALVE. THE PHYSICIAN TRIED A NON-EDWARDS BAV BALLOON AND A BUDDY BALLOON UNSUCCESSFULLY. AFTER SEVERAL ATTEMPTS TO CROSS THE VALVE, WITH THE VALVE REMOVED, THE TEAM DECIDED TO ABORT THE CASE. THE VALVE WAS THEN UNSUCCESSFUL AT GOING BACK INTO THE CERTITUDE SHEATH AND ON THE WAY OUT, SHREDDED THE CAROTID. THE PATIENT "SUPPOSEDLY HAD MULTIPLE POSITION WEAR AND THE CAROTID TORE IN MULTIPLE PARTS". THE SURGEON HAD TO PLACE A PATCH TO FIX IT. THE PATIENT WAS STABLE POST OP AND EVENTUALLY WAS DISCHARGED HOME. ADDITIONAL INFORMATION NOTED THERE WAS NO DAMAGE OBSERVED ON ANY OF THE DEVICES. THERE WAS NO RETAINED VOLUME IN THE BALLOON CAUSING THE WITHDRAWAL DIFFICULTIES. WHEN THE TEAM TRIED TO PULL BACK THE BALLOON BACK INTO THE SHEATH THE VALVE MOVED OFF OF THE BALLOON AND THEY WEREN'T ABLE TO GET IT FULLY INTO THE SHEATH. THE PATIENT WAS "TREATED WITH MDT".

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Vascular Problem

  MAUDE report 22090118 ↗
• MalfunctionJun 14, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, IN A TRANSAORTIC TAVR PROCEDURE WITH A 29 MM SAPIEN 3 IN THE NATIVE AORTIC ANNULUS, THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED DURING THE FINAL STAGES OF THE VALVE INFLATION. DURING REMOVAL, THE RUPTURED BALLOON WOULD NOT COME BACK THROUGH THE SHEATH. WHILE TRYING TO REMOVE THE DELIVERY SYSTEM, THE NOSE CONE, BALLOON AND WIRE LUMEN BECAME DETACHED FROM THE DELIVERY SYSTEM. A HEMOSTAT WAS USED THROUGH THE PURSE STRINGS ALREADY PLACED IN THE AORTA AND THE SURGEON WAS ABLE TO REMOVE ALL COMPONENTS THROUGH THE AORTA. THE ANGIOGRAM AND ECHO SHOWED A FULLY DEPLOYED VALVE WITH NO PARAVALVULAR LEAK. PURSE STRING WAS COMPLETED, AND HEMOSTASIS WAS ACHIEVED. A CIRCUMFERENTIAL BALLOON RUPTURE WAS OBSERVED UPON BALLOON REMOVAL. THE PATIENT WAS TRANSFERRED TO THE UNIT IN STABLE CONDITION. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS NOT PERFORMED PRE-IMPLANT. THE DELIVERY SYSTEM WAS PREPPED WITH NOMINAL VOLUME. THE SPEED OF THE INFLATION TECHNIQUE WAS SLOW. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS A POSSIBLE BALLOON DEFECT. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538620 ↗
• MalfunctionMar 14, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT. VALVE DEPLOYED WITH NO ISSUES. THE DELIVERY SYSTEM WAS RETRIEVED WITH NO ISSUES. THE BALLOON WAS FULLY INFLATED WHEN IT BURST AND THERE WAS NO EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO INFLATION. THE LANDING ZONE FOR THE VALVE HAD SEVERE CALCIUM. CLOSURE OF VENTRICULOTOMY WAS UNCOMPLICATED. THE BALLOON RUPTURE WAS ATTRIBUTED TO CALCIUM IN THE ANATOMY. THE PATIENT IS DOING WELL. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903309 ↗
• MalfunctionJun 6, 2022Material Rupture; Material Rupture

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), AFTER VALVE DEPLOYMENT OF A 29 MM SAPIEN 3 VALVE IN THE NATIVE AORTIC VALVE VIA CAROTID APPROACH THE BALLOON RUPTURED. THE BALLOON RUPTURE OCCURRED AFTER ALL OF THE VOLUME WAS INFLATED INTO THE BALLOON. THE PATIENT IS STABLE. THE VALVE IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605013 ↗
• DeathMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, POST VALVE DEPLOYMENT OF A SAPIEN 3 VALVE IN THE NATIVE MITRAL POSITION VIA TRANSATRIAL, A TEAR IN THE VENTRICLE WALL WAS NOTED. A .035 WIRE WAS INSERTED THROUGH THE DELIVERY SYSTEM TO PROTECT THE VENTRICLE DURING DEPLOYMENT. IT WAS THOUGHT A PERFORATION FROM THE NOSE CONE OF THE CERTITUDE DELIVERY SYSTEM OCCURRED. THE TEAR WAS SUCCESSFULLY REPAIRED AND THERE WAS NO BLEEDING AT THE SITE. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS HAVING SOME PRESSURE ISSUES AS THEY CAME OFF PUMP. THEY WERE ABLE TO STABILIZE HER AND WAS TRANSFERRED FOR POST MANAGEMENT CARE. APPROXIMATELY 3 DAYS POST PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. OF NOTE, THE PATIENT WAS ADMINISTERED HIGH DOES OF PRESSER SUPPORT POST-OPERATIVE. PER REPORT, THE PATIENT HAD A SMALL VENTRICLE.

  Patient problems: Cardiac Perforation

  MAUDE report 14515981 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A WEEK POST OPEN MAC TRANSCATHETER VALVE REPLACEMENT THE PATIENT WAS TAKEN TO THE CATH LAB TO CLOSE PVL AROUND THE VALVE. THE VALVE WAS NOT SEALING AROUND THE MITRAL CALCIUM THE PVL WAS DESCRIBED AS MODERATE TO SEVERE PER THE TEAM AT THE TIME OF THE INTERVENTION. A COMMANDER DELIVERY SYSTEM WITH EXTRA VOLUME WAS INITIALLY USED TO POST DILATE THE VALVE, BUT THE PVL DID NOT DECREASE. PVL WAS THEN CLOSED WITH A PLUG AND THE LEAK WAS DESCRIBED AS MILD. A VSD WAS NOTED AND A PLUG WAS PLACED. THE VSD WAS NOTED IN THE OR BY THE ECHO TEAM. THE TEAM THOUGHT IT MAY HAVE BEEN THE DELIVERY SYSTEM NOSE CONE THAT MAY HAVE CAUSED IT. THE PATIENT LEFT THE CATH LAB IN STABLE CONDITION BUT HAS SINCE EXPIRED OF UNKNOWN CAUSES.

  Patient problems: Perforation

  MAUDE report 13804092 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY AN EDWARD LIFESCIENCES FIELD CLINICAL SPECIALIST, DURING IMPLANTATION OF A 29MM SAPIEN 3 VALVE IN THE NATIVE MITRAL POSITION VIA CERTITUDE DELIVERY SYSTEM, THE NOSE CONE OF THE DELIVERY SYSTEM PERFORATED THE LEFT VENTRICLE (LV) DURING OPEN MITRAL IN MAC APPROACH. THE LV PERFORATION WAS REPAIRED SURGICALLY AND THE PATIENT RECEIVED A TRANSFUSION. THE PATIENT WAS DOING VERY WELL POST OPERATIVELY DAY ONE AND ON DAY TWO DEVELOPED SEPSIS REQUIRING PRESSORS. THE PRESSOR REQUIREMENT INCREASED AND HER WHITE COUNT DROPPED SIGNIFICANTLY, THEY BROUGHT HER BACK TO THE OR FOR AN EXPLORATORY SURGERY TO MAKE SURE HER BOWEL WAS NOT NECROSED, IT WAS CONFIRMED NOT TO BE NECROSED. ON POST OP DAY 3, THE PATIENT EXPIRED.

  Patient problems: Cardiac Perforation

  MAUDE report 11776862 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140031. One submission often covers many models, so check the product and lot details in each record.

• Z-0835-2019 · Jan 22, 2019 · Terminated
  Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 0
• Z-2435-2018 · Jun 11, 2018 · Terminated
  Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
• Z-0293-2018 · Jul 21, 2017 · Terminated
  Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delive