PENTARAY NAV High-Density Mapping Catheter — Class II medical device recall Z-0212-2018
Terminated recall by Biosense Webster, Inc., reported 2017-12-13, distributed nationwide. Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should
| Recall number | Z-0212-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2017-05-17 |
| Classified | 2017-12-07 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2020-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KR, KW, LB, LU, LV, MX, MY, NL, NO, NZ, OM, PL, PT, QA, RO, SA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 73,796 units |
| UPC / GTIN / UDI-DI | 10846835012217, 10846835012224, 10846835012231, 10846835012248, 10846835012255 |
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.
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-0212-2018. 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.