Food, drugs, devices › Edwards Lifesciences, LLC
Device recall: Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are d
FDA enforcement event 77802 is a device recall by Edwards Lifesciences, LLC of Irvine, CA, initiated 6 Jul 2017 and classified Class II, with 1 product record.
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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 17 Oct 2018. Initiation: voluntary: firm initiated. Edwards Lifesciences, LLC has 50 enforcement events on this register, with a median of 1 product record 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
Edwards Lifesciences, LLC, Irvine, CA.
Reason for recall
"The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm."
Distribution
"Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3077-2017 | Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are… | 200 units | Class II | Terminated | 6 Sep 2017 |
Context
Other enforcement events for Edwards Lifesciences, LLC
All 50 events for Edwards Lifesciences, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm."
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: "Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Oct 2018. "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.