Edwards Certitude Delivery System 9630TA23Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103201185), received between Aug 11, 2021 and Mar 26, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Burst Container or Vessel; Inflation Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT WAS UNDERGOING A TRANSCAROTID VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 23 MM SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS BEING IMPLANTED INSIDE A NON-EDWARDS VALVE. DURING THE PROCEDURE, THERE WAS RESISTANCE WHEN ADVANCING THE CERTITUDE DELIVERY SYSTEM WITH VALVE THROUGH THE 21FR CERTITUDE SHEATH, BUT THE DELIVERY SYSTEM WITH VALVE WAS ABLE TO EXIT THE TIP OF THE SHEATH. AFTER EXITING THE TIP OF THE SHEATH, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE STRUTS OF THE NON-EDWARDS VALVE. IT WAS NOTED THAT THE IMPLANTING TEAM WAS BEHIND THE STRUTS OF THE NON-EDWARDS VALVE. THE DELIVERY SYSTEM CROSSED THE STRUTS AT THE MID VALVE PART OF THE VALVE AND WAS ON THE OUTSIDE OF THE NON-EDWARDS VALVE. THE SHEATH WAS PULLED BACK AND THEN THE SHEATH WAS USED TO PROVIDE MORE SUPPORT WHEN IT WAS NOTICED THAT THE TIP OF THE CERTITUDE SHEATH HAD "BROKE OFF". THE TIP OF THE SHEATH WAS NOTED TO BE STUCK AROUND THE SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS NOT DEPLOYED. THE DELIVERY SYSTEM WITH VALVE AND SHEATH WERE REMOVED AS A SINGLE UNIT. A NEW 21FR CERTITUDE SHEATH AND 23 MM CERT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703096 ↗
• MalfunctionMay 5, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE BY TRANSAORTIC APPROACH, THE 23 MM CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED WITH A LONGITUDINAL TEAR AT THE END OF DEPLOYMENT. A 23 MM SAPIEN 3 ULTRA VALVE WAS SUCCESSFULLY IMPLANTED. THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. CAUSE WAS UNKNOWN. THE DELIVERY SYSTEM WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965181 ↗
• InjuryJan 17, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PER REPORT, A VASCULAR SURGEON WAS CALLED TO PATCH A DISSECTION AT THE ACCESS SITE. THE PATIENT REMAINED STABLE.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 21183170 ↗
• InjuryMar 16, 2023Burst Container or Vessel; Material Fragmentation; Difficult to Remove; Burst Container or Vessel; Material Fragmentation; Difficult to Remove

  PER PHOTO PROVIDED, IT APPEARED THE BALLOON WAS SEPARATED. PER THE FCS, ALL BALLOON MATERIAL WAS ACCOUNTED FOR UPON REMOVAL. THE SEPARATION OF THE BALLOON WAS BELIEVED TO BE CAUSED BY THE WITHDRAWAL DIFFICULTY.

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

  MAUDE report 16557660 ↗
• MalfunctionAug 11, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAORTIC TAVR PROCEDURE FOR A 23MM SAPIEN 3 ULTRA VALVE, THE CERTITUDE DELIVERY SYSTEM BALLOON BURST DURING INFLATION. THE VALVE APPEARED FULLY DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. THE SINOTUBULAR JUNCTION (STJ) HAD CALCIUM PRESENT. THE PATIENT LEFT ROOM IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311137 ↗

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