Cordis Avanti Catheter Sheath Introducer System Recalled for Incorrect Cannula Size
Cordis Corporation is recalling 1,985 units of the Avanti Catheter Sheath Introducer System because the cannula is smaller than intended.
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: The recall is classified as FDA Class II. The hazard involves a medical device defect (incorrect cannula size) which poses a risk of harm during percutaneous entry, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cordis Corporation is recalling 1,985 units of the Cordis Avanti + Catheter Sheath Introducer System. The recall is due to the presence of an incorrect cannula in the sheath introducer that is smaller than intended. The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator, which are used to facilitate percutaneous entry of intravascular devices.
The affected units are identified by Catalog No. 504656X (GTIN: 20705032010389), Lot No. 17305580, and an expiration date of July 31, 2018. These units were distributed nationwide in the United States, including in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, West Virginia, and Hawaii.
Healthcare facilities and consumers should stop using the affected products and contact Cordis Corporation for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the…
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Catheter
- Affected units
- 1,985
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580
- Expiration date: 2018-07-31.
Distribution
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