Cordis Guiding Catheters Recalled for Frayed Mounting Card Fragments
Cordis Corporation is recalling Vista Brite Tip and Androit guiding catheters because frayed pieces of the mounting card were found inside the primary packaging.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which is defined as unlikely to cause adverse health consequences. The defect is a packaging issue (frayed mounting card pieces) with no reported injuries or illnesses.
Plain-English summary
Cordis Corporation is recalling Cordis Vista Brite Tip and Androit Guiding Catheters. The recall is due to the presence of frayed pieces of the mounting card inside the primary packaging of the devices.
These guiding catheters are intended for use for intravascular introduction of interventional or diagnostic devices into the coronary or peripheral vascular systems. The affected products were distributed worldwide, including nationwide in the United States, Puerto Rico, Guam, Singapore, and Canada.
The source text does not specify the number of affected units, specific lot numbers, or dates of distribution. It also does not report any illnesses or injuries associated with this defect. Consumers and healthcare providers should check their inventory for the affected products and follow instructions from Cordis Corporation or the FDA regarding the return or disposal of these devices.
The recalled product
- Product
- 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.
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 23,481
Distribution
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