# FDA recall Z-0212-2018

> **Biosense Webster, Inc.** · Class II · device recall initiated 2017-05-17.

## Product

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

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.

## Key facts

- **Recall number:** Z-0212-2018
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-17
- **Report date:** 2017-12-13
- **Termination date:** 2020-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irwindale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0212-2018

## Citation

> AI Analytics. FDA recall Z-0212-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0212-2018. Source: US FDA. Licensed CC0.

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