Freudenberg Medical recalls Empower Introducer Sheaths with hydrophilic coating (model 668782-200) due to potential embolism from non-intended glue causing peripheral ischemia. 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 668782-200) because non-intended glue inside the catheter shaft may cause embolism, leading to reduced blood flow in limbs. This is a serious risk for medical users during procedures.
The sheath contains non-intended glue that can break off inside the catheter shaft during use. This glue may travel to the bloodstream, blocking blood flow in limbs and causing tissue damage. The risk is highest during medical procedures where the sheath is inserted.
Medical professionals using the Empower Introducer Sheath for procedures are most at risk. Patients receiving these sheaths during medical treatments could experience reduced blood flow in limbs.
Check for model number 668782-200 on the sheath. Lot numbers PD02 and PD00013142, and UDI 00802526618000 are associated with this recall.
Immediately stop using the Empower Introducer Sheath with hydrophilic coating (model 668782-200) if it has lot numbers PD02 or PD00013142.
The model number is 668782-200.
Lot numbers PD02 and PD00013142 are affected.
Check for model number 668782-200, lot numbers PD02 or PD00013142, and UDI 00802526618000 on the sheath.
We’ve drafted a message you can send Freudenberg Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1017-2022 — Freudenberg Medical Freudenberg Medical Hello, I own a Freudenberg Medical that is covered by recall Z-1017-2022 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.
