Catheter Sheath Introducer Recalled for Size Labeling Discrepancy
Cordis Corporation is recalling 680 Avanti® Catheter Sheath Introducer units because the actual product dimensions are larger than the labeling indicates.
The agency’s classification
FDA (Devices): Class II
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.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a medical device with a dimensional specification discrepancy. The product is larger than labeled, which could affect proper fit and placement during arterial and venous procedures. No illnesses or injuries have been reported, making this a risk-of-harm product without reported injury per the severity rubric.
Plain-English summary
Cordis Corporation is recalling 680 units of the Avanti® Catheter Sheath Introducer (catalog 504-657A) used in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
The recalled units were manufactured under lot numbers 17919780 (expiration date 12/31/2022) and 17988227 (expiration date 10/31/2023). The product has been found to have inner and outer diameters that are larger than indicated on the product labeling.
The affected units were distributed worldwide, with specific US distribution in Arkansas, Arizona, Florida, Georgia, Indiana, North Carolina, New Jersey, and West Virginia, as well as Canada.
Healthcare facilities that have received affected units should contact Cordis Corporation for further information and instructions regarding the use or replacement of this product.
The recalled product
- Product
- Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
- Manufacturer
- Cordis Corporation
- Affected units
- 680
Distribution
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