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Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System,SmartSite 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-1165-2024 |
| Recall Event ID |
93919 |
| Product Classification |
External cerebrospinal fluid (CSF) diversion - Product Code PCB
|
| Product |
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, 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:
221343119 00613994445391;
221612695 00613994445391;
221873429 00613994445391;
221873431 00763000406011;
222082062 00613994445391;
222480771 00763000406011;
222480772 00763000406011;
223565026 00763000624798;
223580361 00763000624798;
223580378 00763000624798;
223618474 00763000624798;
223621056 00763000624798;
223659561 00763000624798;
223907224 00613994445391;
223907225 00613994445391;
223956150 00613994445391;
223999042 00613994445391;
223999043 00613994445391;
224032609 00613994445391;
224128508 00763000406011;
224387126 00763000406011;
224852795 00613994445391;
224852796 00613994445391;
224878536 00613994445391;
224949834 00613994445391;
224949835 00613994445391;
224990657 00763000624798;
224990660 00613994445391;
224990846 00613994445391;
224990847 00763000624798;
224990889 00763000624798;
225198821 00613994445391;
225500036 00613994445391;
225500037 00613994445391;
225675930 00763000406011;
225675932 00613994445391;
225686835 00613994445391;
225749841 00763000406011;
226111239 00613994445391;
226242273 00763000624798;
226288883 00763000624798;
226335146 00613994445391;
226335147 00763000624798;
226335148 00613994445391;
226366036 00763000624798;
226420635 00763000406011;
226420636 00763000624798;
226517902 00613994445391;
226567491 00763000624798;
226616245 00763000624798;
226734637 00763000624798;
226734639 00763000624798;
226734641 00763000624798;
226734643 00763000624798;
226734645 00763000624798;
226734686 00763000624798;
226756274 00613994445391;
226899371 00763000406011;
226899373 00763000624798;
226899375 00613994445391;
226899378 00613994445391;
226899379 00613994445391;
226899380 00613994445391;
227007688 00763000406011;
227136780 00763000624798;
227188109 00763000624798;
227307931 00763000406011
|
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 |
11,840 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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