Edwards recalls SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) due to burst balloons causing difficulty retrieving the device during procedures. Affected units have UDI:00690103201260; all lots.
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
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Contact the company
📍Recalling firmEdwards Lifesciences, LLC1 Edwards Way · Irvine, CA 92614-5688
“Edwards SAPIEN 3 Ultra Heart Valve Recall: Burst Balloons Cause Retrieval Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67460-edwards-sapien-3-ultra-heart-valve-recall-burst-balloons-cause. Based on FDA recall #Z-2227-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2227-2019%22&limit=1).
Edwards Lifesciences, LLC voluntarily recalled the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) on July 9, 2019, according to the FDA. The recall addresses reports of burst balloons causing difficulty retrieving the device during procedures.
The recall addresses 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. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since July 6, 2017. Recent brand recalls include an Edwards EVOQUE Tricuspid Delivery System labeling update warning on March 27, 2026, and an Optisite Arterial Cannula recall regarding exposed wire risk on May 14, 2025. Other recent recalls of similar products include a Medline Open Heart Kit recall with risk of check valve sticking (Nov. 26, 2025) and Medline convenience kits recalled for rubber fragment risk (Feb. 16, 2026).
How to tell if you have this one
Check for the UDI code 00690103201260 on the valve system packaging or device. The product is the SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) with model number 9630TF29.
Brand
Edwards
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
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
Recall number
Product, codes & lots
Quantity
Z-2224-2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239; All Lots
362 units
Z-2225-2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246; All Lots
2208
Z-2226-2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253; All Lots
2579 Units
Z-2227-2019
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260; All Lots
1754
Based on the official FDA remedy
What to do — step by step
Check Device Packaging
Look for the UDI code 00690103201260 on the valve system packaging or device.
Where it went and when
Where it was distributed
Distributed in 12 states, and outside the U.S.
Listed by the agency
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Georgia, Kansas, Maryland, Massachusetts, Minnesota, New York, Oregon, Tennessee, Virginia, Washington.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2227-2019 (July 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2227-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.