UnratedMedical device recall · FDA · Published February 21, 2022
Freudenberg Empower Introducer Sheath Recall: Embolism Risk from Non-Intended Glue
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.
“Freudenberg Empower Introducer Sheath Recall: Embolism Risk from Non-Intended Glue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61123-freudenberg-empower-introducer-sheath-recall-embolism-risk-from-non-intended. Based on FDA recall #Z-1016-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1016-2022%22&limit=1).
The FDA announced on Feb. 21, 2022, that Freudenberg Medical, Llc is recalling the Empower Introducer Sheath with Hydrophilic Coating due to a potential embolism hazard. The recall involves 13 units distributed in Georgia, Ohio, and the Netherlands.
How to tell if you have it
Brand: Freudenberg Medical
Product: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm
Model: 668782-100 (US)
Lot Numbers: PD01, PD00013140
UDI: 00850004312001
The hazard
According to the FDA, non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause embolism leading to peripheral ischemia.
Context
GovInfoNow's records show Freudenberg Medical, Llc has one other recall on record since June 17, 2026, involving incorrect labeling of Blom-Singer Classic Voice Prosthesis boxes. Other recent recalls of similar products include the Boston Scientific FARADRIVE Steerable Sheath Recall (June 11, 2026) and the Boston Scientific FARADRIVE Steerable Sheath Clear IDE Recall (June 11, 2026).
How to tell if you have this one
Check for the model number 668782-100 (US) on the sheath. Affected units have lot numbers PD01 or PD00013140 and UDI 00850004312001.
Brand
Freudenberg Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US distribution: GA, OH Foreign distribution: Netherlands
Recall number
Product, codes & lots
Quantity
Z-1016-2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US); Lot Numbers: PD01, PD00013140 UDI: 00850004312001
13 units (US)
Z-1017-2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS); Lot Numbers: PD02, PD00013142 UDI: 00802526618000
8 units (OUS)
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number, lot numbers, and UDI to confirm if your sheath is affected.
Where it went and when
Where it was distributed
Distributed in Georgia and Ohio, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US distribution: GA, OH Foreign distribution: Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, Ohio.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1016-2022 (February 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1016-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.