Recall Z-1117-2021 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED 22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL 23093 -
| 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 | 20,817 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
| K792007 | CSF-VENTRICULAR CATHETER, STANDARD DES Pudenz-Schulte Medical Research Corp., Jan 16, 1980 |
| K831678 | P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR Pudenz-Schulte Medical Research Corp., Jun 24, 1983 |
| K841442 | P-S MEDICAL CSF-FLOW CONTROL VALVE- P-S Medical, Apr 19, 1984 |
| K873247 | CSF-FLOW CONTROL VALVE, ULTRA SMALL Pudenz-Schulte Medical Research Corp., Sep 18, 1987 |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT Pudenz-Schulte Medical Research Corp., Sep 18, 1995 |