Edwards Certitude Delivery System 9630TA20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103201444), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING A TAO TAVR CASE THE 20MM CERTITUDE DELIVERY SYSTEM BALLOON RUPTURED DURING VALVE DEPLOYMENT WHEN THE VALVE WAS FULLY INFLATED WITH +3CC'S. THE DECISION WAS MADE TO NOT POST DILATE DUE TO PATIENT CALCIFICATION LOAD AND GREAT HEMODYNAMICS/ECHO RESULTS. THE PATIENT'S STJ WAS SEVERELY CALCIFIED AND SMALL WITH SHARP PROTRUDING CALCIFICATION. THE TEAM FELT THE RISK OF POST-DILATION OUTWEIGHED THE BENEFIT. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849652 ↗

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