Recall Z-0918-2014— Edwards Lifesciences, LLC
Class II · Terminated
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2014-01-20, terminated 2014-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.. Reason: 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..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-20
- Terminated
- 2014-03-24
- Firm location
- Draper, UT, United States
Product description
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.