Z-0871-2021Class II

REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO -

Name: Z-0871-2021 REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO -
Creator: Medtronic Neurosurgery
Published: 2020-12-16
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2020-12-16 / Open, Classified / root cause: design

FDA source

Medtronic Neurosurgery began a recall of REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are... on 2020-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0871-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-16
Posted: 2021-01-15
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.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: 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 tag: design
FDA 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 [email protected] or via fax to 651-367-7075 within 30 days of receipt.
Quantity in commerce: 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.
Product codes and lots: Lot # 0219927059, 0220149614, 0220393237, 0220601648,0220601649, 0220813029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0871-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0871-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-27	2021-01-15
Z-0872-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-27	2021-01-15
Z-0873-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-27	2021-01-15

Product code JXG

K902783Class IIPs Medical Delta Csf-Flow Control ValvePudenz-Schulte Medical Research Corp. / cleared 1990-08-08

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)