The Recall Desk
HighFDA (Devices)·Z-1017-2022·Announced 2022-05-04

Empower Introducer Sheath recalled for potential embolism and ischemia risk

Freudenberg Medical is recalling Empower Introducer Sheath devices (Model 668782-200) due to potential adhesive residue inside the catheter shaft that may cause blood clots and tissue damage. Affected devices were distributed in the US and Netherlands.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving potential embolism and peripheral ischemia from adhesive residue defect, with no reported illnesses or injuries. Meets rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Freudenberg Medical, LLC is recalling the Empower Introducer Sheath with Hydrophilic Coating (Model 668782-200), a medical device used to introduce catheters into blood vessels. The device is 21F x 56cm in size.

The recall was issued because non-intended adhesive residue from the hub/shaft bond may be present inside the catheter shaft. This residue has the potential to cause embolism (blood clots) leading to peripheral ischemia (tissue damage from reduced blood flow).

Affected devices were distributed in the United States (Georgia and Ohio) and internationally (Netherlands). Lot numbers PD02 and PD00013142 are involved. The device UDI is 00802526618000.

If you have received or used this device, contact your healthcare provider immediately. Do not use any additional units from the recalled lot numbers. Healthcare facilities should isolate affected inventory and follow the manufacturer's instructions for handling and return.

The recalled product

Product
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Manufacturer
Freudenberg Medical, Llc
Category
Medical Device — Cardiovascular Access Device
Hazard
Affected units
8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: PD02
  • PD00013142 UDI: 00802526618000

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Freudenberg Medical, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Freudenberg Medical, Llc

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Same hazard · embolism

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