Recall Z-1116-2021 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815 - SHUNT 27815 STRATA II ASSY REG, 27816 - SHUNT 27816 SNAP STRATA II SMALL, 27817 - SHUNT 27817 S
| 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 | 22,528 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
| K033850 | MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE Medtronic Neurosurgery, Jan 13, 2004 |
| K042465 | PS MEDICAL STRATA II VALVE Medtronic Neurosurgery, Oct 19, 2004 |
| K060681 | MEDTRONIC PS MEDICAL STRATA TYPE VALUE Medtronic Neurosurgery, Sep 15, 2006 |
| K083076 | STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 Medtronic Neurosurgery, Nov 20, 2008 |
| K123524 | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM Medtronic Neurosurgery, Feb 13, 2013 |