FDA Device recall Z-1016-2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
- FDA Device
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) by Freudenberg Medical, citing non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1016-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-21 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Freudenberg Medical |
| Distribution | GA, OH |
Product
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Reason
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Identifiers
| code_info | Lot Numbers: PD01, PD00013140 UDI: 00850004312001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1016-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.