FDA MedWatch - Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation

 

Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation

AUDIENCE: Radiology, Cardiology, Risk Manager

ISSUE: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due to reports of separation of the tip of the catheter from the main body. Tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs.

Tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health consequences, including death.

The recalled products include manufacturing dates: November 7, 2003 to October 18, 2008, and distribution dates January 5, 2004 to December 3, 2008. See the FDA Recall Notice for a listing of affected lot numbers.

BACKGROUND: The Soft-Vu Omni Flush Angiographic Catheter is used to inject contrast dye into blood vessels in preparation for a cardiac angiogram, a type of X-ray used to diagnose heart conditions. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel.

RECOMMENDATION: On June 1, 2016, Stryker Sustainability Solutions sent a Customer Notification letter to customers informing them of the high possibility of tip separation during use. The letter also asked customers to:

• Discontinue use of the affected lots of the recalled products
• Check their inventories for affected lots of the unused products
• Ship all affected products found back to Stryker
• Acknowledge receipt of the letter by returning the enclosed Device Recall Effectiveness Check form by postal mail, or by contacting their Stryker Sustainability Sales Representative by email at ssspfa@xxxxxxxxxxx

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm512644.htm

 

---

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)