SHERPA NX ACTIVE GUIDING CATHETER — Class I medical device recall Z-2610-2019
Completed recall by Medtronic Vascular, reported 2019-10-09. There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid
| Recall number | Z-2610-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Danvers, MA, United States |
| Recall initiated | 2019-03-15 |
| Classified | 2019-09-30 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2024-04-26 |
| Countries outside the US | AT, BE, BG, CZ, DE, ES, FR, GB, GR, HK, IE, IT, LU, NL, PL, PT, SA, SE, SK, TW, ZA |
| Quantity | 246 units |
| UPC / GTIN / UDI-DI | 00613994823816 |
| Model numbers | A63DRCSH |
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use
Reason for recall
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
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-2610-2019. 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.