Edwards Certitude Delivery System 9630TA29Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103201451), received between Mar 29, 2021 and Feb 21, 2025 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Burst Container or Vessel; Difficult to Remove; Material Separation; Burst Container or Vessel; Difficult to Remove; Material Separation

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING AN INNOMINATE ARTERY TAVR PROCEDURE WITH A 29MM SAPIEN 3 VALVE, THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED TOWARDS THE END OF DEPLOYMENT. PER TEE, THE VALVE WAS WELL DEPLOYED WITH NO LEAKAGE, SO THE TEAM ATTEMPTED TO BRING THE DELIVERY SYSTEM BACK INTO THE SHEATH, HOWEVER RESISTANCE WAS MET. AFTER MULTIPLE MANEUVERS, THE FRONT NOSE CONE AND DISTAL PORTION OF THE BALLOON BECAME DETACHED FROM THE REST OF THE DELIVERY SYSTEM. THE TEAM ELECTED TO TRY TO SNARE THE REMAINING PART OF THE SYSTEM WHILE ON THE WIRE, BUT WAS UNABLE TO AFTER MULTIPLE ATTEMPTS. SO THE TEAM ELECTED TO ATTEMPT SNARING THE REMAINING PARTS OF THE SYSTEM VIA FEMORAL ACCESS WITH A 22FR DRYSEAL. THIS ATTEMPT WAS SUCCESSFUL. ANGIOS AND TEE WERE PERFORMED, AND THE TEAM FELT THEY DIDN'T SEE ANY INJURY TO THE PATIENT. THE PATIENT WAS TRANSFUSED DUE TO BLOOD LOSS. PER REPORT, THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435675 ↗
• MalfunctionDec 23, 2021Burst Container or Vessel; Burst Container or Vessel

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT DURING A TRANSAPICAL TAVR IN AN UNKNOWN SURGICAL VALVE THE CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED AFTER THE 29 SAPIEN 3 VALVE WAS FULLY INFLATED. AS REPORTED, THERE WAS A CHUNK OF CALCIUM IN ANNULUS. A BALLOON AORTIC VALVULOPLASTY WAS NOT PERFORMED. THERE WAS NO EXTRA VOLUME ADDED TO THE BALLOON PRIOR TO THE INFLATION. THE INFLATION TECHNIQUE WAS SLOW. NOMINAL VOLUME WAS USED FOR INFLATION. A LONGITUDINAL AND LATERAL TEAR OF BALLOON WAS OVERSERVED. THE DELIVERY SYSTEM WAS SAFELY REMOVED AND THERE WAS NO HARM TO THE LV. THERE WERE NO NEGATIVE OUTCOMES OR PATIENT INJURIES. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078471 ↗
• MalfunctionSep 2, 2021Difficult to Advance; Difficult to Advance

  DIFFICULTIES WERE ENCOUNTERED CROSSING A PRE-EXISTING TRICUSPID SURGICAL VALVE DURING A VALVE IN VALVE (VIV) PROCEDURE. DIFFICULTIES WERE ALSO ENCOUNTERED DURING THE WITHDRAWAL OF THE CERTITUDE DELIVERY SYSTEM, RESULTING IN MOVEMENT OF A SAPIEN 3 VALVE ON THE DELIVERY SYSTEM BALLOON. DURING AN OFF-LABEL TRANS-JUGULAR TRICUSPID VIV PROCEDURE, A 29MM SAPIEN 3 VALVE AND CERTITUDE DELIVERY SYSTEM WOULD NOT CROSS THE PRE-EXISTING SURGICAL VALVE. THE DECISION WAS MADE TO PERFORM A BALLOON VALVULOPLASTY. DIFFICULTIES WERE ENCOUNTERED DURING THE WITHDRAWAL OF THE DELIVERY SYSTEM AND VALVE. THE VALVE COULD NOT BE PULLED INTO THE 21FR SHEATH AND WAS PUSHED 4MM TOWARD THE NOSE CONE. THE VALVE WAS SUCCESSFULLY DEPLOYED IN THE SUPERIOR VENA CAVA (SVC). THE PROCEDURE WAS THEN CONVERTED TO THE TRANSFEMORAL APPROACH. A NEW VALVE AND COMMANDER DELIVERY SYSTEM WERE PREPARED. FOLLOWING BALLOON VALVULOPLASTY, THE NEW SAPIEN 3 VALVE WAS SUCCESSFULLY DEPLOYED IN THE PRE-EXISTING TRICUSPID SURGICAL VALVE. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. ALL VALVES REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418274 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EDWARDS RECEIVED NOTIFICATION FROM AN FIELD CLINICAL SPECIALIST THAT AN SAPIEN 3 VALVE WAS STRIPPED OFF THE DELIVERY SYSTEM AND EMBOLIZED INTO THE LEFT VENTRICULAR OUTFLOW TRACT(LVOT). AS REPORTED, THIS PATIENT WAS A TA APPROACH DUE TO SIGNIFICANT CALCIUM BURDEN AT THE OTHER ALTERNATE ACCESS SITES. THERE WAS A HEAVY CALCIUM BURDEN AT THE LVOT. DURING THE TA APPROACH WITH THE CERTITUDE DELIVERY SYSTEM, THE PHYSICIANS FELT THAT THE VALVE GOT CAUGHT ON THE LVOT CALCIUM. WHEN THE PHYSICIAN TRIED TO PULL BACK THE SYSTEM AND REPOSITION IT, THE VALVE WAS STRIPPED OFF THE DELIVERY SYSTEM AND EMBOLIZED INTO THE LV. EMERGENT ECMO WAS INITIATED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE EMBOLIZED VALVE THROUGH THE TA INCISION AND A NEW SHEATH, CERTITUDE DELIVERY SYSTEM AND VALVE WERE USED TO COMPLETE THIS PROCEDURE. THE PATIENT REMAINED UNDER CRITICAL OBSERVATION IN THE CCU. THE LAST KNOWN STATUS IS THAT PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586715 ↗

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