FDAFDA · Food and drugs·Recall number Z-0918-2014
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Published February 12, 2014 · Recall initiated: January 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- Nationwide Distribution
- Lot
- lot 59617777 and 59658495.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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