Freudenberg Medical recalls Empower Introducer Sheath Model 668782-100 (US) due to potential embolism from non-intended glue in the catheter shaft. Affected units have specific lot numbers and UDI.
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Freudenberg Medical is recalling Empower Introducer Sheaths with Hydrophilic Coating (Model 668782-100) because non-intended glue inside the catheter shaft may cause embolism, leading to tissue damage. This recall affects medical devices used in procedures requiring catheter insertion.
The sheath contains non-intended glue that can leak into the catheter shaft during use. This glue may travel to the bloodstream, causing embolism which can block blood flow and lead to tissue damage or death.
Healthcare professionals using the Empower Introducer Sheath for procedures like catheter insertions are most at risk. Patients receiving these devices during medical procedures may also be affected.
Check for the model number 668782-100 (US) on the sheath. Affected units have lot numbers PD01 or PD00013140 and UDI 00850004312001.
Identify the model number, lot numbers, and UDI to confirm if your sheath is affected.
The official recall notice states that non-intended glue inside the catheter shaft may cause embolism, so it is not safe to use without checking for recall details.
The recall record does not specify a remedy, so you should check the product details to see if it is affected and contact Freudenberg Medical for further instructions.
Affected units have model number 668782-100 (US), lot numbers PD01 or PD00013140, and UDI 00850004312001.
We’ve drafted a message you can send Freudenberg Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1016-2022 — Freudenberg Medical Freudenberg Medical Hello, I own a Freudenberg Medical that is covered by recall Z-1016-2022 from Freudenberg Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
