Empower Introducer Sheath Recalled for Defective Glue and Embolism Risk
Freudenberg Medical is recalling the Empower Introducer Sheath due to defective adhesive on the catheter shaft that could cause blood clots and tissue damage.
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: This is an FDA Class II recall of a risk-of-harm medical device where the potential hazard is serious—embolism leading to peripheral ischemia—but no illnesses or injuries have been reported. The theoretical nature of the hazard combined with the lack of reported incidents supports a High severity score.
Plain-English summary
Freudenberg Medical, LLC is recalling the Empower Introducer Sheath with Hydrophilic Coating (Model 668782-100, 21F x 56cm). This is a medical device used in vascular procedures to introduce catheters.
The recall was issued because non-intended glue is present on the hub/shaft bond on the inside of the catheter shaft. This glue could break free and cause an embolism (blood clot) that may lead to peripheral ischemia (reduced blood flow to affected tissues).
The recall affects 13 units distributed in the United States (Georgia and Ohio) and the Netherlands. Affected units have lot numbers PD01 or PD00013140, with UDI 00850004312001.
Patients and healthcare providers should contact Freudenberg Medical if they have received affected units. Clinicians should immediately cease use of any units matching the recalled lot numbers.
The recalled product
- Product
- Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
- Manufacturer
- Freudenberg Medical, Llc
- Hazard
- embolism
- adhesive-defect
- peripheral-ischemia
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: PD01
- PD00013140 UDI: 00850004312001
Distribution
Distributed in 2 states:
- GA
- OH
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