Recall Z-0740-2021 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, 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.
| Date | Dec 8, 2020 |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 quali |
| Quantity | 3,858 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, Ire |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110560 | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER Medtronic Neurosurgery, Nov 18, 2011 |