Edwards Lifesciences Crimpers Recalled for Potential Sterile Barrier Pouch Holes
Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.
What this means for you
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. The hazard involves a potential breach of the sterile barrier, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Edwards Lifesciences, LLC is recalling 6,117 units of Model 9100CR26 Crimpers. These devices are used to crimp the transcatheter heart valve onto the delivery system prior to use. The recall covers all lot numbers of this model.
The recall is being issued because holes in the sterile barrier pouch may be present. The source text indicates that these holes may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers. This defect poses a risk to the sterility of the device.
The affected units 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. Users should contact Edwards Lifesciences for instructions on how to return or replace the affected devices.
The recalled product
- Product
- Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 6,117
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 9100CR26
- 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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