Z-2225-2019Class I

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23...

Name: Z-2225-2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23...
Creator: Edwards Lifesciences, LLC
Published: 2019-07-09
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2019-07-09 / Terminated

FDA source

Edwards Lifesciences, LLC began a recall of Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246 on 2019-07-09. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2225-2019
Classification: Class I
Status: Terminated
Initiated: 2019-07-09
Posted: 2019-08-21
Terminated: 2020-09-15
Recalling firm: Edwards Lifesciences LLC
Product: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
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
FDA root cause: Other
Action: On July 09, 2019 the firm sent an Urgent Field Safety Notice REF: FCA - 141 to consignees via FEDEx Priority Overnight. The Urgent Field Safety Notice informs consignees of the following: 1. When deploying the valve, inflate the balloon slowly and continuously throughout deployment. Hold for 3 seconds at full inflation. " The delivery system requires a prescribed volume for THV deployment and proper function (11 mL, 17 mL, 23 mL, 33 mL). 2. The following warning will also be added to the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System IFU: " Failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, difficulty retrieving the delivery system, and may require subsequent conversion to surgical intervention. 3. If a balloon burst is suspected, do not attempt to pull back the delivery system into the sheath until you are prepared to conduct the following technique: A. Close stopcock to the delivery system and remove inflation device from stopcock. B. Continuously twist the handle in a clockwise direction (full 360 degree rotations) while gently pulling back the delivery system into the sheath tip. Verify delivery system tip has entered the sheath tip under fluoroscopy. C. DO NOT FORCE if resistance is met near or at the sheath tip. Forcing retrieval when meeting resistance could result in additional balloon material tearing or tip dislodgement. Consider utilizing other interventional techniques for retrieval (e.g. a snare). D. If successful in pulling the entire balloon into the tip of the sheath, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position. DO NOT attempt to pull the delivery system through the remaining length of the sheath. E. If resistance is still encountered, convert to surgery for device removal. Based on medical assessment of the size, tortuousity,
Quantity in commerce: 2208
Distribution: 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
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2225-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2224-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2225-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2226-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21
Z-2227-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)