FDA MedWatch - Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage

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Title: FDA MedWatch - Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage

AUDIENCE: Risk Manager, Surgery

ISSUE: Bard Peripheral Vascular Inc. is recalling the Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient's leg. The company also reports that the sheath may kink, and that its tip may become damaged during the procedure.

The use of affected sheaths may result in prolonged procedure times and on additional surgical intervention to remove detached components from the patient. The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.

• Product Codes: HAL545, HAL590, HAL510F
• Manufacturing Dates: April 12, 2016 to July 7, 2016
• Distribution Dates: June 24, 2016 to July 12, 2016

See the Recall Notice for affected lot numbers

BACKGROUND: The Halo One Thin-Walled Guiding Sheath is used to introduce and/or guide the placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient's leg.

RECOMMENDATION: On January 10, 2017, Bard Peripheral Vascular sent a Medical Device Recall Notification, which instructed consignees to:

• Stop using, or further distributing, any affected products
• Check all inventory locations for affected product codes and lot numbers
• Remove any affected products from the shelves
• If an affected product has been used, complete and return the "Recall and Effectiveness Check Form," which was attached to the notification, and which indicates no product will be returned
• Contact the firm's Recall Coordinator at 1-800-321-4254 Option #2 Ext. 2501 (Monday - Friday 6am to 3pm Mountain Standard Time) or by email at raye.seisinger@xxxxxxxxxx

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 Recall Notice, at

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538831.htm

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