PENTARAY NAV High-Density Mapping Catheter.
Reported: December 13, 2017 Initiated: May 17, 2017 #Z-0211-2018
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.
Details
- Recalling Firm
- Biosense Webster, Inc.
- Units Affected
- 73,796 units total
- Distribution
- 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.
- Location
- Irwindale, CA
Frequently Asked Questions
What product was recalled? ▼
PENTARAY NAV High-Density Mapping Catheter.. Recalled by Biosense Webster, Inc.. Units affected: 73,796 units total.
Why was this product recalled? ▼
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0211-2018.
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