EDWARDS CERTITUDE DELIVERY SYSTEM 9600SDS23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103194142), received between Feb 24, 2023 and Jan 30, 2025 — classified as 2 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSCAROTID APPROACH, A NATIVE BASILICA OF THE LEFT LEAFLET WAS PERFORMED WITH EFFACED SINUSES. THE RIGHT CORONARY WAS ALSO WIRED BECAUSE OF POTENTIAL RISK OF CORONARY OCCLUSION WITH AN EFFACED SINUS. BASILICA, CAROTID ACCESS, CORONARY ACCESS, CERTITUDE SHEATH PLACEMENT AND VALVE DEPLOYMENT WERE ALL ACHIEVED WITH SUCCESS. POST VALVE DEPLOYMENT ON TRANSESOPHAGEAL ECHO, THERE WAS TRIVIAL LEAK BELOW THE LEFT CUSP. ON ANGIOGRAM, THE LEAK WAS MUCH WORSE, AND THE DECISION WAS MADE TO POST DILATE WITH 1 ADDITIONAL CC OF VOLUME. WHEN THIS WAS PERFORMED, THE CERTITUDE BALLOON RUPTURED CIRCUMFERENTIALLY. UPON TRYING TO REMOVE THE BALLOON THROUGH THE CERTITUDE SHEATH, THE FLANGES GOT CAUGHT ON AND WOULD NOT ALLOW THE DELIVERY SYSTEM TO BE REMOVED. THE SURGEON REMOVED THE SHEATH WITH THE BALLOON FLANGES FLARED WHICH DISSECTED THE LEFT CAROTID ARTERY. THE PROCEDURE TURNED INTO A VASCULAR REPAIR WITH A GRAFT ADDED TO THE LEFT CAROTID ARTERY. THE PATIENT LEFT THE TABLE ALIVE AND STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 21275887 ↗
• MalfunctionAug 1, 2023Material Rupture; Material Rupture

  AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE, REGARDING IMPLANT OF A 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA CAROTID APPROACH. THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT. THE IMPLANTERS BELIEVE A PIECE OF CALCIUM ON THE STJ CAUSED THE THE BALLOON TO RUPTURE. NO HARM TO THE PATIENT WAS NOTED AT THIS.

  Patient problems: Insufficient Information

  MAUDE report 17436701 ↗
• InjuryFeb 24, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A CAROTID TAVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE, DURING FULL DEPLOYMENT OF THE VALVE, THE 23 MM CERTITUDE DELIVERY DEVICE BALLOON RUPTURED. THE PATIENT HAS A HEAVILY CALCIFIED SINOTUBULAR JUNCTION (STJ) AND ASCENDING AORTA. THE BALLOON WAS FULLY INFLATED WHEN IT BURST. THE PATIENT REMAINED HYPOTENSIVE POST DEPLOYMENT. CPR WAS INITIATED AND EPI WAS GIVEN AND THE PATIENT FULLY RECOVERED. THE VALVE WAS POST DILATED WITH A 22MM ATLAS GOLD BALLOON. THE VALVE WAS POST DILATED BECAUSE THE PHYSICIAN WANTED TO MAKE SURE THE VALVE WAS FULLY EXPANDED SINCE THE DELIVERY BALLOON RUPTURED DURING THE END OF DEPLOYMENT. THE PHYSICIAN HAD TO USE SOME FORCE TO PULL THE DELIVERY OUT OF THE SHEATH BUT THERE WAS NO DAMAGE TO THE SHEATH AND THE BALLOON WAS INTACT. THE PATIENT WAS STABLE AT THE END OF THE CASE AND THERE WAS MILD PARAVALVULAR LEAK AND NO CENTRAL LEAK OBSERVED. PER THE FCS, THE PATIENT HAD A SEVERELY CALCIFIED STJ. THERE WAS NO EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO INFLATION. THE PATIENT'S PRESSURE STARTED TO DROP PRIOR TO DEPLOYMENT, ONCE THE SAPIEN 3 VALVE CROSSED THE NATIVE VALVE. THE PERCEIVED ROOT CAUSE OF THE HYPOTENSI

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16436972 ↗

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