Prelude SNAP Splittable Sheath Introducer — Class II medical device recall Z-2238-2021
Terminated recall by Merit Medical Systems, Inc., reported 2021-08-18, distributed in AL, AR, CA, CO, DE, FL, GA, HI…. There is a potential that 7F sheaths are packaged as 10F sheaths.
| Recall number | Z-2238-2021 |
|---|---|
| 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 | 2021-06-30 |
| Classified | 2021-08-10 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2023-02-24 |
| Distributed | AL, AR, CA, CO, DE, FL, GA, HI, IA, IL, KY, MA, MD, ME, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, RI, TX, VA, VT, WI |
| Countries outside the US | NO |
| Quantity | 760 units |
| UPC / GTIN / UDI-DI | 00884450489611 |
| Lot numbers | I2067768 |
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Reason for recall
There is a potential that 7F sheaths are packaged as 10F sheaths.
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-2238-2021. 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.