Edwards Lifesciences Recalls 26mm Transcatheter Heart Valve Crimpers
Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a high-risk medical device where a functional defect could impede proper procedure preparation, but no injuries or illnesses are reported in the source text.
Plain-English summary
Edwards Lifesciences, LLC is recalling two lot numbers (59617777 and 59658495) of the 26mm transcatheter heart valve crimper (Model 9100CR26). A total of 422 units were distributed nationwide. The device is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
The recall was initiated because the crimpers may not open sufficiently when the handle is rotated to the full open position. As a result, users may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
Healthcare providers and facilities should stop using the affected crimpers and contact Edwards Lifesciences for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 422
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)
- lot 59617777 and 59658495.
Distribution
Distributed nationwide across the United States.
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