Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 469
FDA device recall Z-1923-2014 · posted 2014-06-27 · Terminated
Recall details
- Recalling firm
- Medtronic Neurosurgery
- Reason for recall
- 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.
- Action taken
- 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 the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 1,187 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, Rus
- Date initiated
- 2014-06-09
- Date posted
- 2014-06-27
- Date terminated
- 2015-01-14
- Location
- Goleta, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM (K984053) | Medtronic PS Medical | 1999-02-04 |