Recall Z-2371-2020— BIOSENSE WEBSTER
Class II · Terminated
Class II FDA medical device recall by BIOSENSE WEBSTER, initiated 2020-04-22, terminated 2022-12-15. It names one FDA 510(k) clearance: K120425. Product: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.. Reason: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map..
- Recalling firm
- BIOSENSE WEBSTER
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-22
- Terminated
- 2022-12-15
- Firm location
- IRVINE, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Reason for recall
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Data sourced from openFDA. This site is unofficial and independent of the FDA.