Recall Z-0845-2011 ยท HCG Device, Neurovascular Embolization
Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131
Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. Catalog Numbers: PC4180933, SSR181128, CPL100252, PC4181647, SSR181640, CPL100404, DFS100254, SSR181230, CPL100406, DFS100410, DPL100206, SRC141230, CRC140304
| Date | Jan 3, 2011 (initiated Oct 21, 2010) |
| Status | Terminated |
| Reason | The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm. |
| Root cause | Other |
| Action | Micrus Endovascular Corp sent Urgent: Medical Device Recall Letters dated October 21, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine inventory (including consignment) and quarantine the product to prevent it from being used or shipped. If the product was further distributed, customers were to notify their customers by sending a copy of the recall letter and were instructed to work with all customers to ensure that all product was returned and that pre-use protocol was followed. The res |
| Quantity | 6755 |
| Distribution | Worldwide Distribution - USA including AK, AL, AZ, CA, CO, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Ir |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062036 | MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 Micrus Endovascular Corporation, Aug 25, 2006 |
| K072173 | MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC Micrus Endovascular Corporation, Oct 5, 2007 |
| K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL Micrus Endovascular Corporation, Jan 2, 2009 |