Edwards Lifesciences, LLC: Medical Device Recall in 2019 - (Recall #: Z-2227-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260

Product Classification:

Class I

Date Initiated: July 9, 2019

Date Posted: August 28, 2019

Recall Number: Z-2227-2019

Event ID: 83293

Reason for Recall:

The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures

Status: Terminated

Product Quantity: 1754

Code Information:

All Lots

Distribution Pattern:

US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria

Voluntary or Mandated:

Voluntary: Firm initiated