Recall Z-1042-2024 ยท KRD Device, Vascular, For Promoting Embolization
BALT USA, LLC
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the anomaly, and thrombosing the target site. The Prestige Coil System is comprised of the implant coil an
| Date | Feb 8, 2024 (initiated Jan 3, 2024) |
| Status | Open, Classified |
| Reason | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli. |
| Root cause | Material/Component Contamination |
| Action | On 01/03/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via priority mail to customers informing them that Balt USA has became aware of a situation where discoloration along the delivery system pusher component of the Optima Coil System was identified during in-house inspection of released finished good products. The discoloration was observed on the outside of the PET jacket along the hypotube component. Customers are instructed to: 1) Stop or cease use of the affected recall product. 2) Inform their hospital staff, such as safety officers, pharmacists, purchasing agent, head |
| Quantity | 2802 coils |
| Distribution | U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Ecuador, France, Indonesia, India, Japan, Korea, Malaysia, Mexico, Panama, Paraguay, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220699 | Prestige Coil System Bait USA, LLC, Apr 8, 2022 |