Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Ster

FDA device recall Z-1164-2024 · posted 2024-02-27 · Open, Classified

Recall details

Recalling firm

Medtronic Neurosurgery

Reason for recall

Potential for catheter disconnection from the patient line stopcock connectors.

Action taken

On January 23, 2024, Medtronic CSF issued a "URGENT: MEDICAL DEVICE RECALL" Notification to affected consignees via mail. Medtronic CSF asked consignees to take the following actions: 1. Immediately identify and quarantine any unused impacted product(s). 2. Return all unused and non-expired product(s) in your inventory to Medtronic. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. 3. Work with your Medtronic Rep to receive an RGA# or contact us at 1-800-874-5797, Option 1, to coordinate inventory replacement/credit. Reference FA1400, Lot Number, and Product Number. 4. Reference the RGA# in the attention line when returning the affected product. Credit for products returned without an RGA# may be delayed. 5. Return unopened affected units to: Medtronic, Attention: [Insert RGA #], 4340 Swinnea Rd., Building B, Returns cage, Memphis, TN 38118 6. Complete and return the Customer Confirmation Form, even if you do not have any unused affected product to return via email to neuro.quality@medtronic.com within 30 days of receipt. If you have any questions regarding this communication, please contact your Medtronic representative.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PCB

Quantity affected

14,139 units

Distribution

Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI,

Date initiated

2024-01-22

Date posted

2024-02-27

Location

Irvine, CA