Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model:… — Class II medical device recall Z-1016-2022
Terminated recall by Freudenberg Medical, Llc, reported 2022-05-04, distributed in GA, OH. Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to
| Recall number | Z-1016-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Freudenberg Medical, Llc, Jeffersonville, IN, United States |
| Recall initiated | 2022-02-21 |
| Classified | 2022-04-28 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2024-04-18 |
| Distributed | GA, OH |
| Countries outside the US | NL |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 00850004312001 |
| Lot numbers | PD00013140, PD01 |
| Model numbers | 668782-100 |
Product
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Reason for recall
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
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-1016-2022. 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.