| | Class 2 Device Recall Medtronic Delta CSFFlow Control Valves and Shunts |  |
| Date Initiated by Firm | January 11, 2021 |
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| Create Date | February 12, 2021 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1115-2021 |
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| Recall Event ID |
87157 |
| 510(K)Number | K042465 K862907 K902783 K951258 |
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| Product Classification |
Shunt, central nervous system and components - Product Code JXG
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| Product | Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers:
24048 - VALVE 24048 DELTA RGL PL 0.5,
24053 - CHAMBER 24053 DELTA,
24147 - VALVE 24147 DELTA SML PL0.5,
25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120,
25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120,
25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0,
25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0,
25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5,
25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0,
25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5,
27219-1 - VALVE 27219-1 NEONATE DELTA,
27219-2 - VALVE 27219-2 NEONATE DELTA,
27219-5 - VALVE 27219-5 DELTA NEONATE 1.5 IMP,
27554-1 - VALVE 27554-1 DELTA SM EXTRACTED PL 1.0,
27554-2 - VALVE 27554-2 DELTA SM EXTRACTED PL 2.0,
27554-5 - VALVE 27554-5 DELTA SM EXTRACTED PL 1.5,
42812 - VALVE 42812 DELTA SMALL LEVEL I,
42813 - VALVE 42813 DELTA SMALL LEVEL 1.5,
42814 - VALVE 42814 DELTA SMALL LEVEL II,
42822 - VALVE 42822 DELTA REG PRESS LEVEL I IMP,
42823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5,
42824 - VALVE 42824 DELTA REG PRESS LEVEL II IMP,
46812 - ASSY 46812 DELTA SHUNT SMALL PL 1,
46813 - ASSY 46813 DELTA SHUNT SM LEV 1.5,
46822 - ASSY 46822 DELTA SHUNT REG P/L 1,
46823 - ASSY 46823 DELTA SHUNT REG LEV 1.5,
46824 - ASSY 46824 DELTA SHUNT REG P/L 2,
46832 - SHUNT 46832 NEONATAL DELTA SNAP L 1,
46833 - SHUNT 46833 NEONATAL DELTA SNAP 1.5,
46834 - SHUNT 46834 NEONATAL DELTA SNAP L 2,
92822 - VALVE 92822 BIOGLIDE DELTA REG. 1.0,
92823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5, |
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| Code Information |
Lot numbers for the affected CFNs: 0218796596, 0220173993, 0220631950, 0218806959, 0219354642, 0220201977, 0219404900, 0219404902, 0219501288, 0219501289, 0219869817, 0219278742, 0219278743, 0219278744, 0219698794, 0219809171, 0219948890, 0220112694, 0220180486, 0220217387, 0220262088, 0220397742, 0220397744, 0219272923, 0220279501, 0219278741, 0219927059, 0220149614, 0220393237, 0219281777, 0219948893, 0220166870, 0220236215, 0220720015, 0220285334, 0220285335, 0220285336, 0217135294, 0218720240, 0218720241, 0218992842, 0219621242, 0220251046, 0217135293, 0218720605, 0218721466, 0218721467, 0218721468, 0218992826, 0218992827, 0219154178, 0219289039, 0219289040, 0219312362, 0219761091, 0217135298, 0218720604, 0219284249, 0219284250, 0219761089, 0217150648, 0217244574, 0217244584, 0218721469, 0218721470, 0218986445, 0217135290, 0217286224, 0217344860, 0217344861, 0218720187, 0218753744, 0218753745, 0219312363, 0219800605, 0219802486, 0217135295, 0217135302, 0219423220, 0219761099, 0219279163, 0219278857, 0219278858, 0220352837, 0220398089, 0219279162, 0220400352, 0220602457, 0219279147, 0220352830, 0220088041, 0220602458, 0220285342, 0219894798, 0220398845, 0220285343, 0219067896, 0219067897 |
Recalling Firm/
Manufacturer |
Medtronic Neurosurgery
5290 California Ave
Irvine CA 92617-3073
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Manufacturer Reason
for Recall | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus |
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FDA Determined
Cause 2 | Process control |
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| Action | On January 11, 2011, the firm issued an "URGENT: Medical Device Correction" notification to all affected consignees. In addition to informing consignees about the correction, the firm ask consignees to take the following actions;
1. Be aware that radiopaque marker visualization with impacted devices under radiographic imaging may be
insufficient to determine the pressure level and/or flow direction. In these situations, alternative methods
for this determination should be considered, if deemed necessary per clinical discretion.
2. Share this information within your organization to healthcare professionals who monitor patients
implanted with these devices.
3.If desired, radiographic imaging of packaged devices may be conducted pre-operatively to determine
marker radiopacity. However, marker visibility of packaged devices under radiographic imaging may not be
representative of marker visibility post-implant.
4. Complete and return the enclosed confirmation form to acknowledge receipt of this notification.
Additional Information:
Medtronic will honor the return of these products for full credit. If you require a return goods authorization, you
can visit http://connect.medtronic.com to initiate your return that is less than 90 days old. For returns over 90
days old, please contact Customer Care directly at 1-800-874-5797. Please ensure that you reference FCA 2020-
12-08-CSF along with the affected batch number(s), original purchase order and/or invoice number, to facilitate return goods authorization. For any new order placement, please provide a new purchase order to your customer
care representative.
Please maintain a copy of this letter for your records.
Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality
problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event
Reporting program via:
-E-mail Medtronic at RS.MNSProdExperience |
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| Quantity in Commerce | 2911 units |
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| Distribution | Worldwide distribution. US nationwide, Albania,
Algeria,
Argentina,
Armenia,
Australia,
Austria,
Bahrain,
Bangladesh,
Belgium,
Plurinational State Of Bolivia,
Bosnia And Herzegovina,
Botswana,
Brazil,
Brunei Darussalam,
Bulgaria,
Canada,
Canary Islands,
Cayman Islands,
Chile,
China,
Colombia,
Costa Rica,
Croatia,
Curacao,
Cyprus,
Czech Republic,
Denmark,
Dominican Republic,
Ecuador,
Egypt,
El Salvador,
Finland,
France,
Gabon,
Georgia,
Germany,
Ghana,
Greece,
Guatemala,
Honduras,
Hong Kong,
Hungary,
Iceland,
Indonesia,
Islamic Republic Of Iran,
Iraq,
Ireland,
Israel,
Italy,
Jamaica,
Japan,
Jordan,
Kazakhstan,
Republic Of Korea,
Kuwait,
Lao People's Democratic Republic,
Latvia,
Lebanon,
Libyan Arab Jamahiriya,
Lithuania,
Macao,
Malaysia,
Malta,
Mauritania,
Mexico,
Montenegro,
Netherlands,
New Zealand,
Nicaragua,
Nigeria,
North Macedonia,
Norway,
Oman,
Pakistan,
Panama,
Papua New Guinea,
Paraguay,
Peru,
Philippines,
Poland,
Portugal,
Puerto Rico,
Qatar,
Romania,
Russian Federation,
Saudi Arabia,
Serbia,
Singapore,
Slovakia,
South Africa,
South Korea,
Spain,
Sri Lanka,
Sudan,
Sweden,
Switzerland,
Taiwan,
Thailand,
Trinidad And Tobago,
Tunisia,
Turkey,
Ukraine,
United Arab Emirates,
United Kingdom,
Uruguay,
Uzbekistan,
Viet Nam,
and Yemen |
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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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| 510(K) Database | 510(K)s with Product Code = JXG
510(K)s with Product Code = JXG
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