PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath… — Class II medical device recall Z-0688-2018
Terminated recall by Merit Medical Systems, Inc., reported 2018-02-28. Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable She
| Recall number | Z-0688-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2017-12-14 |
| Classified | 2018-02-22 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-07-10 |
| Countries outside the US | AU, BH, IL, MY, RS, ZA |
| Quantity | 60,945 devices |
| Lot numbers | Q1161477, Q1170938, Q1174112, Q1175815, Q1175817, Q1176345, Q1176347, Q1176348, Q1176349, Q1178762, Q1182836, Q1182862, Q1182863, Q1184987, Q1185050, Q1190097, Q1193391, Q1193397, Q1193985, Q1194041, Q1194660, Q1194661, Q1194663, Q1194664, Q1194665, Q1197054, Q1197055, Q1197331, Q1201789, Q1201803, Q1202959, Q1204708, Q1205118, Q1206565, Q1206577, Q1209475, Q1209478, Q1213018, Q1213024, Q1213042 and 15 more |
| Model numbers | PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5 |
Product
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
Reason for recall
Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
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-0688-2018. 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.