Recall Z-1924-2014 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
| Date | Jun 27, 2014 (initiated Jun 9, 2014) |
| Status | Terminated |
| Reason | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about th |
| Quantity | 35 units |
| Distribution | Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984053 | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM Medtronic PS Medical, Feb 4, 1999 |