FDA Medical Device Recalls (openFDA)
Medtronic Neurosurgery: REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.
- Recall number
- Z-0871-2021
- Recalling firm
- Medtronic Neurosurgery
- Product
- REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.
- Status
- Open, Classified
- Initiated
- 2020-12-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
- Root cause
- Device Design
- Action
- On 12/16/2020, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to affected customers via FedEx. In addition, to notifying consignees about the recall, the firm ask consignees to take the following actions: 1. Identify, segregate, and quarantine affected valves within your inventory. 2. Contact Medtronic to return affected valves and receive replacement(s). See instructions below. 3. Please complete and return the customer confirmation form, even if you do not have any affected valves. 4. Return the form via email to RS.NavFCA@Medtronic.com or via fax to 651-367-7075 within 30 days of receipt.
- Quantity
- 95 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MI, MO, NV, NM, NY, ND, OH, OK, TN, VA and the countries of Albania, Australia, Brazil, Cyprus, Ireland, Mexico, Qatar, Romania, Russian Federation, Serbia, South Africa, Spain, United Kingdom.
- Lot, serial or model codes
- Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029
- 510(k) numbers
- ["K902783"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 3015531529
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28