Device recall: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Freudenberg Medical, Llc (Jeffersonville, IN) initiated this device recall on 21 Feb 2022; FDA lists 2 product records under event 89882, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 18 Apr 2024. Initiation: voluntary: firm initiated. Freudenberg Medical, Llc has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Freudenberg Medical, Llc, Jeffersonville, IN.
Reason for recall
"Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia"
Distribution
"US distribution: GA, OH Foreign distribution: Netherlands"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1016-2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) | 13 units (US) | Class II | Terminated | 4 May 2022 |
| Z-1017-2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS) | 8 units (OUS) | Class II | Terminated | 4 May 2022 |
Context
Other enforcement events for Freudenberg Medical, Llc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 Jun 2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF | Device | Class II | 2 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution: GA, OH Foreign distribution: Netherlands"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Apr 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.