Z-0211-2018 Class II Terminated
FDA device recall Z-0211-2018 was initiated by Biosense Webster, Inc. on May 17, 2017 and is designated Class II. Reason for recall: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. The recall status is terminated (terminated December 15, 2020). Affected quantity: 73,796 units total.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- May 17, 2017
- Termination Date
- December 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73,796 units total
Product Description
Reason for Recall
Distribution Pattern
Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.