Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes
Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.
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: The recall is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier for a medical device used in heart valve procedures, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling 5,472 units of Model 9100CR23 Crimpers. These devices are used to crimp transcatheter heart valves onto delivery systems prior to use. The recall covers all lot numbers of this specific model.
The recall is being issued because holes in the sterile barrier pouch may be present. The source text indicates these holes may be caused by handling of the device during manufacturing or by customers after the pouches have been removed from the unit box and stored on the shelf. The presence of holes in the sterile barrier could potentially compromise the sterility of the device.
The affected products were distributed nationwide in the United States, including the District of Columbia and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. Healthcare facilities and customers should stop using the affected crimpers and contact Edwards Lifesciences for instructions on return or replacement.
The recalled product
- Product
- Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 5,472
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 (2)
- Models 9100CR23
- all lot numbers.
Distribution
Part of a larger recall action
This product is one of 2 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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