Medtronic Neurosurgery 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, 25 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

Recommended Action

Per FDA guidance

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