Recalls / —
—#117023
Product
Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
- FDA product code
- NPT — Aortic Valve, Prosthesis, Percutaneously Delivered
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P100041, P110021
- Affected lot / code info
- Models 9100CR26, all lot numbers.
Why it was recalled
Holes in the sterile barrier pouch 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.
Root cause (FDA determination)
Package design/selection
Action the firm took
Edwards Lifesciences notified customers via letter and instructed them to maintain the device in its protective unit carton until ready for use and to inspect the pouch for holes or tears prior to use as instructed in the product's labeling. If any holes or tears are found, customers are instructed to contact Edwards Customer Service to arrange for return and replacement of damaged product.
Recalling firm
- Firm
- Edwards Lifesciences, LLC
- Address
- 12050 Lone Peak Pkwy, Draper, Utah 84020-9414
Distribution
- Distribution pattern
- Nationwide Distribution-USA (nationwide) including DC 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.
Timeline
- Recall initiated
- 2013-03-26
- Posted by FDA
- 2013-04-17
- Terminated
- 2013-09-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #117023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.