FDA MedWatch - Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers by Cook Medical: Class I Recall - Due to Separation in Device

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers by Cook Medical: Class I Recall - Due to Separation in Device AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Cook Medical is recalling the Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) because of an increased chance of separation at a specific point (proximal bond site). If the device separates during use, this may lead to life-threatening adverse events. Use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury, and bleeding. There have been 57 complaints about this device issue and 14 reports of serious injuries. There have been no reported deaths. For product photos, full list of catalog and lot numbers about this recall click on red button "Read Recall" below. BACKGROUND: The Cook Medical Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) are catheters that have a coated shaft, a valve, a dilator, and markers that show up on an x-ray. The catheters help insert other medical devices used for therapy or diagnosis into the vessels, except those of the heart and brain, during surgery or other procedures. RECOMMENDATION: Cook Medical sent an Urgent Medical Device Recall notification letter to all affected customers letting them know the company is removing all devices potentially affected from the market. The letter also provided the following instructions for customers: Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form. Share the Urgent Medical Device Recall notification letter with appropriate staff, including down to the user level, within the organization, or with any organization where the potentially affected devices have been transferred. Immediately report adverse events to Cook Medical Customer Relations. Health 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. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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