| | Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter |  |
| Date Initiated by Firm | January 22, 2024 |
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| Date Posted | February 27, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1166-2024 |
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| Recall Event ID |
93919 |
| Product Classification |
External cerebrospinal fluid (CSF) diversion - Product Code PCB
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| Product | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume. |
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| Code Information |
Lot Number/GTIN:
222277587 00613994445407;
223565027 00763000624804;
223580362 00763000624804;
223698572 00763000624804;
223734523 00763000624804;
223999040 00763000406028;
224301720 00763000406028;
224302820 00613994445407;
224973997 00613994445407;
224990852 00613994445407;
224990870 00613994445407;
224990871 00613994445407;
225198822 00613994445407;
226490967 00763000624804;
226517899 00763000624804;
226546799 00613994445407;
226571115 00613994445407;
226665388 00763000624804;
226665395 00613994445407;
226734688 00763000624804;
226734689 00763000624804;
226756273 00763000406028 |
Recalling Firm/
Manufacturer |
Medtronic Neurosurgery
5290 California Ave
Irvine CA 92617-3073
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Manufacturer Reason
for Recall | Potential for catheter disconnection
from the patient line stopcock connectors. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Quantity in Commerce | 3, 889 units |
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| 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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