Z-0211-2018 Class II Terminated
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
PENTARAY NAV High-Density Mapping Catheter.
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.
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.
Code Information
Product code (Product Description) (GTIN): D-1282-01-S (NAV, 7FR, F, 4-4-4) (10846835009576), D-1282-02-S (NAV, 7FR, F, 2-6-2) (10846835009583), D-1282-03-S (NAV, 7FR, F, 1-8-1) (10846835009590), D-1282-04-S (NAV, 7FR, D, 4-4-4) (10846835009606), D-1282-05-S (NAV, 7FR, D, 2-6-2) (10846835009613), D-1282-06-S (NAV, 7FR, D, 1-8-1) (10846835009620).