BALT USA, LLC: Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial

Hazard

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.

Details from the source

Reason for recall: 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. 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, Peru, Russia, Uruguay, and Vietnam. Quantity: 31785 coils Lot/code info: Refer to Attachment 1 for list of affected products including the products' Lot Number, Product model number, UDI and expiration date. Optima Coils ( Lot Number/Model Number/Product Description/UDI-DI Code: F201000528 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F201200957 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210100206 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210200292 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210200541 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210300015 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210301053 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053022128 F201000069 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000337 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000484 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000927 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201001145 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100048 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201100121 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100149 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100164 OPTI015

UPC codes

00818053026614, 00818053022128, 00818053025747, 00818053026621, 00818053021411, 00818053022135, 00818053021428, 00818053026638, 00818053025754, 00818053022142, 00818053026645, 00818053025761, 00818053021435, 00818053022159, 00818053026393, 00818053021916, 00818053027086, 00818053022548, 00840303700777, 00818053021978, 00818053026461, 00818053026409, 00818053021923, 00818053021985, 00818053026478, 00818053026485, 00818053021992, 00818053026492, 00818053022005, 00818053026508, 00818053022012, 00818053022029, 00818053026515, 00818053022036, 00818053026522, 00818053026539, 00818053022043, 00818053025709, 00818053021374, 00818053026577

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.