Class 2 Device Recall Medtronic ARES AntibioticImpregnated Catheter

• Date Initiated by Firm: December 08, 2020
• Create Date: December 28, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0738-2021
• Recall Event ID: 86988
• 510(K)Number: K110560
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
• Code Information: Lot Numbers: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 0010353502, 0010384894, 0010149011, 0010289831, 0010305923, 0010353503, 0010384895, 0010149013, 0010289833, 0010305926, 0010353504, 0010384896, 0010258434, 0010289834, 0010316955,, 0010369362, 0010393213, 0010265136, 0010297686, 0010316956, 0010369364, 0010393215, 0010265137, 0010297689, 0010316957, 0010369365, 0010393216, 0010265138, 0010297691, 0010316958, 0010376787, 0010393814, 0010278408, 0010297693, 0010336617, 0010376788, 0010393839, 0010278409, 0010297696, 0010336618, 0010376789, 0010289827, 0010305912, 0010336619, 0010376790, 0010289828, 0010305919, 0010353500, 0010384892
• Recalling Firm/ Manufacturer: Medtronic Neurosurgery; 5290 California Ave; Irvine CA 92617-3073
• Manufacturer Reason for Recall: There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
• FDA Determined Cause: Packaging change control
• Action: On 12/8/2020, Medtronic sent an "Urgent: Medical Device Recall" Notification via FedEx to affected consignees. In addition, to providing consignees information on the recall device, Medtronic ask consignees to take the following actions: 1. Identify, segregate, and quarantine affected products within your inventory. The list of affected lots is included. 2. Contact Medtronic to return affected product and receive replacement(s). See instructions on next page. 3. Please complete and return the customer confirmation form, even if you do not have any affected product 4. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: - E-mail Medtronic at RS.MNSProdExperienceHelp@Medtronic.com or call 1-877-526-5432. Online at the FDA website1 (form available to fax or mail) or call FDA at 1-800-FDA-1088.
• Quantity in Commerce: 3,165 units
• Distribution: Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JXG