Recall Class: Class I
Date Recall Initiated: May 2, 2015
Device: VASCU-GUARD Peripheral Vascular Patch (also referred to as the VASCU-GUARD patch)
|Product Codes||Product Description|
|1504026||VASCU-GUARD TS 1x6cm|
|1504028||VASCU-GUARD TS 0.8x8cm|
|1504030||VASCU-GUARD TS 1x10cm|
|1504032||VASCU-GUARD TS 2x9cm|
- Manufacturing dates: January 19,2015 to May 1, 2015
- Distribution dates: March 16, 2015 to May 1, 2015
- Number of Units Distributed in the US: 3,974
- Number of U.S. Customers: 770
- No Out of US Distribution
Use: The VASCU-GUARD patch is used to rebuild peripheral blood vessels such as the carotid in the neck and the renal in the kidneys. It is also used in arteriovenous access revisions.
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, Illinois 60015
Reason for Recall:
Baxter is recalling the VASCU-GUARD patch because it may be difficult for surgeons to distinguish the smooth side from the rough side of the implant. A change in packaging caused the smooth surface of the patch to be too rough. If the rough side of the patch is implanted in the incorrect way, blood clots (thrombus) may form on the patch. This may expose patients to significant health risks, including the movement of blood clots into the blood stream (embolism), reduced blood flow, stroke, organ failure, or death.
Patients who need repair of smaller arteries are at higher risk of blood clots forming within a blood vessel because of slower flow of blood through those vessels. Patients who have blood disorders where excessive blood clots form may also be at a higher risk of forming clots on the surface of the device.
The firm reported 51 complaints related to this issue and one serious injury.
Customers with questions may contact Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, 7 am to 6 pm, Central Time.
Consumers with questions may contact Baxter at 1-800-422-9837, Monday through Friday, 8 am to 5 pm Central Time, or email Baxter at email@example.com.
FDA District: Minneapolis District Office
More Information about this Recall:
Beginning on May 2, 2015, Baxter Healthcare began sending an Urgent Product Recall letter to customers. The letter identified the product, problem, and action to be taken.
Health Care Facilities should:
- Stop using the recalled device.
- Locate and remove all recalled devices from your facilities.
- Return the devices to Baxter Healthcare.
- Contact Baxter Healthcare Center for Service at 888-229-0001 to arrange for return.
- Complete and return the Customer Reply Form by faxing it to 224-270-5457 or scanning and emailing it to firstname.lastname@example.org.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to these recalled devices.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.