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AVANTI recallZ-1174-2016 · Cordis Corporation · initiated Dec 31, 2015

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cordis Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrect cannula of the sheath introducer (smaller than intended).

FDA root cause category: Mixed-up of materials/components

What the company is doing

The firm, Cordis, sent an 'Urgent MEDICAL DEVICE CORRECTION (Field Safety Notice) dated 12/31/2015 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Read the Description of the problem section carefully to fully understand the issue involved. 2) Check your inventory to determine if you have any remaining affected product in your possession. Check all storage and usage locations. The purpose is to identify the product, not to remove the product. 3) Keep a copy of this notice with any affected product. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis by fax to (908) 429-8287 Alternate fax (904) 928-5077. number or scan and email to [email protected]. 5) Share this letter with anyone who needs to be informed in your facility and in any facility where potentially affected devices may have been transferred. 6) Maintain awareness of this notice until all affected product has been consumed. If vessel dilator to sheath incompatibility is experienced, you can report the incident through the standard complaint process (1-800-327-7714 Option 3). For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730."

Recall details

Recall number
Z-1174-2016
Status
Terminated
Initiated by the company
Dec 31, 2015
Posted by the FDA
Mar 15, 2016
Recalling firm
Cordis Corporation
Quantity
1,985 units
Product code
DRE
FDA submissions
K970392
Distribution
US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.

Product description

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 CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

Code information (models, lots, serial numbers)

Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

27 devices cleared under K970392 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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