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
- Hazard
- embolism
- peripheral-ischemia
- adhesive-residue
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:
- GA
- OH
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