EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS26Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690103194159), received between Mar 18, 2021 and Apr 16, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 18, 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.

• MalfunctionApr 16, 2026Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A LEFT-SIDE TRANS CAROTID TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN THE NATIVE AORTIC POSITION, THE BALLOON TO THE 26MM CERTITUDE DELIVERY SYSTEM (DS) BURST WHILE BEING DEPLOYED. THE DS WAS NOT ABLE TO BE REMOVED THROUGH THE 18FR CERTITUDE SHEATH; THE DS AND SHEATH HAD TO BE REMOVED TOGETHER AS A UNIT. A SECOND AND NEW 18FR CERTITUDE SHEATH WAS THEN INSERTED INTO THE CAROTID ARTERY TO FINISH CLOSING THE ARTERIOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900613 ↗
• InjuryNov 10, 2025Difficult to Insert; Difficult to Insert

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAORTIC TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA RESILIA VALVE, THE 26 MM CERTITUDE DELIVERY SYSTEM AND 26 MM SAPIEN 3 ULTRA RESILIA VALVE WERE INSERTED INTO THE 18FR CERTITUDE SHEATH, BUT THE SYSTEM WOULD NOT ADVANCE THROUGH THE LOADER. THE DELIVERY SYSTEM AND VALVE WERE REMOVED. A SECOND 26 MM CERTITUDE DELIVERY SYSTEM AND 26 MM SAPIEN 3 ULTRA RESILIA VALVE WERE PREPARED. PRIOR TO INSERTING THE SECOND DELIVERY SYSTEM AND VALVE INTO THE CERTITUDE SHEATH, AN ATTEMPT WAS MADE TO ADVANCE THE DELIVERY SYSTEM AND VALVE THROUGH THE LOADER. THE DELIVERY SYSTEM AND VALVE WERE UNABLE TO ADVANCE THROUGH THE LOADER. NO ATTEMPT WAS MADE TO INSERT THE DELIVERY SYSTEM AND VALVE INTO THE CERTITUDE SHEATH. A DECISION WAS MADE TO USE A 26 MM COMMANDER DELIVERY SYSTEM. AT THIS POINT, THE PATIENT REQUIRED BLOOD TRANSFUSIONS DUE TO BLEEDING AROUND THE SHEATH SITE. IT WAS INDICATED THAT THE DIFFICULTY USING THE SAPIEN 3 ULTRA RESILIA VALVE WITH THE CERTITUDE DELIVERY SYSTEM CREATED A DELAY IN PROCEEDING WITH VALVE IMPLANTATION, WHICH ALLOWED FOR EXTRA BLEEDING TIME. A THIRD 26 MM SAPIEN 3 ULTRA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23513681 ↗
• MalfunctionMar 17, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSCAROTID TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN AORTIC POSITION. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING DEPLOYMENT. THE VALVE WAS SUCCESSFULLY DEPLOYED. THE SHEATH AND CERTITUDE DELIVERY SYSTEM WERE REMOVED. PATIENT IS CURRENTLY IN RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617829 ↗
• MalfunctionSep 18, 2024Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE 26MM CERTITUDE BALLOON RUPTURED DURING DEPLOYMENT. THE FCS ADVISED THAT THE RUPTURED WAS VERY DIFFICULT TO REMOVE. THE BALLOON AND SHEATH HAD TO BE REMOVED TOGETHER AND A NEW DELIVERY BALLOON AND SHEATH HAD TO BE INSERTED AND USED TO POST DILATE THE VALVE. THERE WERE NO ISSUES AT THE TIME OF THIS NOTE. UPON FOLLOW UP, THE FCS ADVISED THAT THE BALLOON WAS TORN. THE EVENT WAS AT THE LAST 1 OR 2CCS OF BALLOON INFLATION. AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM THROUGH THE SHEATH, BUT THE BALLOON WINGS WOULD NOT ALLOW. THE ENTIRE SYSTEM, DELIVERY AND SHEATH WERE REMOVED TOGETHER. NO INSTRUMENTS WERE USED TO REMOVE THE BALLOON COVER. NO EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO THE INFLATION. THE SPEED OF THE INFLATION TECHNIQUE WAS SLOW. THERE WAS NO LEAK IN THE DELIVERY SYSTEM NOTICED. BLOOD WAS SEEN IN THE SYRINGE WHEN NEGATIVE PRESSURE WAS PULLED IN THE INFLATION DEVICE. THERE WAS NO DIFFICULTY WITH THE VALVE ALIGNMENT. THERE WAS DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM. THE WITHDRAWAL DIFFICULTY WAS EXPERIENCED AFTER THE BALLOON RUPTURED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252013 ↗
• MalfunctionJul 11, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A CERTITUDE DELIVERY SYSTEM BALLOON BURST DURING INFLATION/DEPLOYMENT OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION BY CAROTID APPROACH. BALLOON INFLATION TECHNIQUE WAS FAST, AND AN ADDITIONAL 2CC OF VOLUME WAS ADDED TO THE BALLOON PRIOR TO INFLATION. SINOTUBULAR JUNCTION CALCIUM IS SUSPECTED AS THE CAUSE OF THE BALLOON BURST. THE VALVE WAS ASSESSED BY PHYSICIANS AND DETERMINED TO BE FULLY EXPANDED. THE COMMANDER DELIVERY SYSTEM WAS WITHDRAWN WITHOUT ISSUE. PATIENT TOLERATED THE PROCEDURE WELL, AND NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726681 ↗
• InjuryNov 22, 2023Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, A PATIENT UNDERWENT A TRANSCAROTID PROCEDURE WITH A 26MM SAPIEN 3 VALVE INSIDE A PRE-EXISTING 27MM FREESTYLE VALVE IN AORTIC POSITION. THIS WAS A PLANNED LEFT CAROTID ACCESS CASE USING A 26MM CERTITUDE DELIVERY SYSTEM AND SHEATH SYSTEM. THE SHEATH, VALVE, AND DELIVERY SYSTEM WERE PREPPED PER IFU. THE 26MM SAPIEN 3 VALVE WAS DEPLOYED WITH 24CC PER PHYSICIANS REQUEST. DURING BALLOON INFLATION, THE BALLOON HAD RUPTURED. THE VALVE WAS DEPLOYED AT 60/40 POSITION. THE SURGEON HAD DIFFICULTY PULLING THE BALLOON BACK INTO THE SHEATH. AS A RESULT, THE CAROTID ARTERY WAS TORN AND NEEDED SURGICAL REPAIR. THE PATIENT REMAINED STABLE DURING THE PROCEDURE. AS PER FOLLOW-UP WITH THE FCS, THE VALVE WAS DEPLOYED AT 60/40 INTENTIONALLY DUE TO CALCIUM. THE VALVE WAS POST-DILATED BECAUSE THE VALVE WAS UNDERDEPLOYED NOT DUE TO PVL. THE BALLOON WAS PARTIALLY INFLATED WHEN IT BURST. THERE WAS 1CC EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO THE INFLATION. THE INFLATION TECHNIQUE USED WAS SLOW AND 24CC OF VOLUME WAS USED FOR INFLATION. THE PERCEIVED ROOT CAUSE OF THE BALLOON BURST IS DUE TO THE CALCIUM. THE DEVICE WAS GETTING CAUGHT AT THE DISTAL TIP DURING WITHDR

  Patient problems: Vascular Dissection

  MAUDE report 18196731 ↗
• InjuryJul 12, 2022Burst Container or Vessel; Burst Container or Vessel

  A CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED DURING THE DEPLOYMENT OF A SAPIEN 3 VALVE IN THE AORTIC POSITION. AS REPORTED BY AN EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSCAROTID TAVR PROCEDURE, ACCESS TO THE CAROTID AND VESSEL DILATION WERE COMPLETED WITHOUT ISSUE. POST DEPLOYMENT OF A 26MM SAPIEN 3 VALVE, BLOOD WAS OBSERVED IN THE INFLATION DEVICE WHEN PULLED NEGATIVE, INDICATING AN APPARENT BALLOON RUPTURE. DIFFICULTIES WERE ENCOUNTERED DURING THE WITHDRAWAL OF THE DELIVERY SYSTEM AND THE DELIVERY SYSTEM WAS NOT ABLE TO BE PULLED BACK INTO THE CERTITUDE SHEATH. AN ATTEMPT WAS MADE TO REMOVE THE DELIVERY SYSTEM AND SHEATH TOGETHER. THE SHEATH WAS REMOVED, HOWEVER THE DISTAL BALLOON SHOULDER DETACHED FROM DELIVERY SYSTEM AND WAS WEDGED AT THE CAROTID OSTIUM. A CUT-DOWN WAS DONE TO EXPOSE THE VESSEL AS CLOSE TO THE OSTIUM AS POSSIBLE AND ATTEMPTS WERE MADE TO GRAB DISTAL SHOULDER/NOSE CONE/ AND REMOVE THE BALLOON FROM THE OSTIUM. THE DISTAL BALLOON WAS GRABBED AND REMOVED. THE CAROTID WAS LIGATED AND REPAIRED. THE PATIENT WAS TRANSFERRED TO POST-OP IN STABLE CONDITION. THE VALVE REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 14987160 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEWING THE MEDICAL RECORDS PROVIDED, IT IS NOTED THAT THE PATIENT HAD A VIV (26MM S3 IN A SURGICAL VALVE) IN THE TRICUSPID POSITION VIA TRANSJUGULAR AND RIGHT FEMORAL VEIN APPROACH. A 26MM SAPIEN 3 VALVE WAS IMPLANTED USING A CERTITUDE DELIVERY SYSTEM THROUGH A 18FR CERTITUDE SHEATH. POST PROCEDURE, THE TEAM REALIZED THE PICC LINE WAS NOT FUNCTIONING. FLUOROSCOPY REVEALED THAT IT WAS CURLED IN THE NECK. THEY DID NOT ATTEMPT TO REPOSITION IT. INSTEAD, A 5F SHEATH WAS PLACED IN THE RIGHT FEMORAL VEIN WITH ULTRASOUND GUIDANCE. THIS WAS TO BE USED UNTIL THE PICC LINE COULD BE CORRECTED. FOLLOW UP CONFIRMED THIS WAS THE SAME SIDE AS THE EDWARDS DEVICES, AND THE ISSUES WITH THE PICC LINE RELATED TO AN INTERACTION WITH THE EDWARDS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934749 ↗
• MalfunctionMar 18, 2021Material Rupture; Material Rupture

  AS REPORTED BY AN EDWARDS FIELD CLINICAL SPECIALIST, DURING DEPLOYMENT OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE CERTITUDE DELIVERY SYSTEM BALLOON BURST. THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED WITH THE ESHEATH WITHOUT ISSUE AND THERE WERE NO PATIENT INJURIES. THE PATIENT HAD MILD PVL ON ANGIO AND TRACE PVL ON TEE. A POST DILATION WAS NOT PERFORMED. PATIENT LEFT THE ROOM IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516230 ↗

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 9600LDS
• 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