Freudenberg Medical, Llc: Medical Device Recall in 2022 - (Recall #: Z-1016-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

Product Classification:

Class II

Date Initiated: February 21, 2022

Date Posted: May 4, 2022

Recall Number: Z-1016-2022

Event ID: 89882

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

Status: Terminated

Product Quantity: 13 units (US)

Code Information:

Lot Numbers: PD01, PD00013140 UDI: 00850004312001

Distribution Pattern:

US distribution: GA, OH Foreign distribution: Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated