Z-1115-2021Class II

Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048...

Name: Z-1115-2021 Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048...
Creator: Medtronic Neurosurgery
Published: 2021-01-11
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2021-01-11 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Neurosurgery began a recall of 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... on 2021-01-11. FDA classified it as Class II and gives the reason as "Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1115-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-11
Posted: 2021-02-12
Recalling firm: Medtronic Neurosurgery
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,
Product code: JXG Shunt, Central Nervous System And Components
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
Root cause tag: manufacturing process
FDA root cause: Process control
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
Quantity in commerce: 2911 units
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1115-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1115-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-12
Z-1116-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-12
Z-1117-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-24	2021-02-12

Product code JXG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)