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Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System,Interlink Injection Sites, Ventricular Cather |
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| Date Initiated by Firm |
January 22, 2024 |
| Date Posted |
February 27, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1164-2024 |
| Recall Event ID |
93919 |
| Product Classification |
External cerebrospinal fluid (CSF) diversion - Product Code PCB
|
| Product |
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume. |
| Code Information |
Lot Number/GTIN:
221604935 00613994445384;
221827829 00613994445384;
222121359 00613994445384;
222125124 00613994445384;
222163140 00613994445384
222163787 00613994445384;
222163788 00613994445384;
222204095 00613994445384;
222204097 00613994445384;
222439027 00613994445384;
222439028 00613994445384;
222439029 00613994445384
222658560 00613994445384;
222658561 00613994445384;
222724791 00613994445384;
222724792 00613994445384;
222766469 00613994445384;
222766470 00613994445384;
222816525 00613994445384;
222817386 00613994445384;
222817387 00613994445384
223818451 00763000624781;
223818452 00763000624781;
223954944 00763000624781;
223956932 00763000624781;
224083877 00613994445384;
224303373 00613994445384;
224303374 00613994445384;
225336444 00613994445384;
225468102 00613994445384;
226242272 00763000624781;
226366038 00613994445384;
226420633 00613994445384;
226420634 00763000624781;
226490981 00613994445384;
226517901 00613994445384;
226546796 00763000624781;
226571114 00763000624781;
226625848 00763000624781;
226632942 00763000624781;
226634688 00763000624781;
226634689 00763000624781;
226634690 00763000624781;
226665393 00763000624781;
226665394 00613994445384;
226665399 00763000624781;
226665400 00763000624781;
226665401 00763000624781;
226665403 00763000624781;
226665404 00763000624781;
226665405 00763000624781;
226665646 00763000624781;
226665647 00763000624781;
226665648 00763000624781;
226665650 00763000624781;
226732001 00763000624781;
226899377 00613994445384;
226951465 00613994445384;
226951467 00613994445384;
226951468 00613994445384;
226951469 00763000396008;
227136777 00763000624781;
227188108 00763000624781;
227194735 00763000624781;
227194736 00763000624781
|
Recalling Firm/
Manufacturer |
Medtronic Neurosurgery
5290 California Ave
Irvine CA 92617-3073
|
Manufacturer Reason
for Recall |
Potential for catheter disconnection
from the patient line stopcock connectors.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
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. |
| Quantity in Commerce |
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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and OUS (foreign): Argentina, Australia, Bahrain, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Gabon, Germany, Ghana, Greece, Hong Kong, Iceland, Iran, Islamic Republic Of Ireland, Italy, Kazakhstan, Kuwait, Latvia, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
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| Total Product Life Cycle |
TPLC Device Report
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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.
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