Pentaray NAV High-Density Mapping Catheter — Class II medical device recall Z-1590-2016
Terminated recall by Biosense Webster, Inc., reported 2016-05-11, distributed nationwide. Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructi
| Recall number | Z-1590-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2016-04-14 |
| Classified | 2016-04-29 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2016-10-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, CA, CH, CN, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KR, LV, MY, NL, NO, NZ, PL, PT, QA, RO, RU, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 13,912 units |
| Reason classes | labeling |
| Model numbers | D128201, D128202, D128203, D128204, D128205, D128206 |
Product
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
Reason for recall
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1590-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.