Recall Z-1115-2021 ยท JXG Shunt, Central Nervous System And Components
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,
| Date | Jan 11, 2021 |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 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, Cos |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042465 | PS MEDICAL STRATA II VALVE Medtronic Neurosurgery, Oct 19, 2004 |
| K862907 | P-S MEDICAL CSF-SIPHON CONTROL DEVICE Pudenz-Schulte Medical Research Corp., Dec 3, 1986 |
| K902783 | PS MEDICAL DELTA CSF-FLOW CONTROL VALVE Pudenz-Schulte Medical Research Corp., Aug 8, 1990 |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT Pudenz-Schulte Medical Research Corp., Sep 18, 1995 |