Recall Z-0212-2018— Biosense Webster, Inc.
Class II · Terminated
Class II FDA medical device recall by Biosense Webster, Inc., initiated 2017-05-17, terminated 2020-12-15. It names 2 FDA 510(k) clearances: K123837, K120425. Product: PENTARAY NAV High-Density Mapping Catheter.. Reason: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves..
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-17
- Terminated
- 2020-12-15
- Firm location
- Irwindale, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K123837 — PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
- K120425 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.