Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons
Edwards Lifesciences is recalling 362 units of the SAPIEN 3 Ultra Transcatheter Heart Valve System due to reports of burst balloons that complicate device retrieval.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect resulted in 'significant difficulty' during procedures, which aligns with the rubric criterion for 'significant injury/property-damage reports' or severe procedural complications, warranting a score of 4.
Plain-English summary
Edwards Lifesciences, LLC is recalling 362 units of the SAPIEN 3 Ultra Transcatheter Heart Valve System (20 mm, model 9630TF20). The recall covers all lots of this specific product configuration.
The action was initiated to address reports of burst balloons. These incidents have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures.
The affected units were distributed in the United States (VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS) and internationally (United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria). Healthcare providers should stop using the affected devices and contact Edwards Lifesciences for further instructions.
The recalled product
- Product
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 362
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 4 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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