Food, drugs, devices › Cordis Corporation
Device recall: Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravasc
Cordis Corporation (Miami Lakes, FL) initiated this device recall on 7 Feb 2019; FDA lists 1 product record under event 82481, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 3 Nov 2021. Initiation: voluntary: firm initiated. Cordis Corporation has 23 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
Cordis Corporation, Miami Lakes, FL.
Reason for recall
"Frayed pieces of the mounting card being inside the primary packaging."
Distribution
"Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1198-2019 | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. | 23481 | Class III | Terminated | 24 Apr 2019 |
Context
Other enforcement events for Cordis Corporation
All 23 events for Cordis Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Frayed pieces of the mounting card being inside the primary packaging."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Nov 2021. "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.