Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons
Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused difficulty retrieving the device during procedures.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency has classified this as an FDA Class I recall, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Edwards Lifesciences, LLC is recalling the SAPIEN 3 Ultra Transcatheter Heart Valve System (26mm) in the United States and several international countries. The recall involves 2,579 units across all lots. The product is distributed in 12 US states and 17 international locations, including the United Kingdom, Canada, and Germany.
The recall 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 agency has classified this as a Class I recall.
Healthcare providers and patients who have received this device should contact Edwards Lifesciences for further instructions on how to proceed with the recall.
The recalled product
- Product
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 2,579
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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