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 emboliz

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: 2802 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. Prestige Coils ( Lot Number/Model Number/Product Description/UDI-DI Code: F201000210 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201000231 PRES1137COM18 Prestige Coil 11mm x 37cm Complex-18 00818053023217 F201000319 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac 00818053027307 F201000320 PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac 00818053027314 F201000321 PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack 00818053027444 F201000322 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201000323 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac 00818053027178 F201000324 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack 00818053027185 F201000325 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack 00818053027192 F201000326 PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack 00818053027208 F201000329 PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack 00818053027550 F201000330 PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack 00818053027581 F201000331 PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac 00818053027109 F201000332 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac 00818053027147

UPC codes

00818053027451, 00818053023217, 00818053027307, 00818053027314, 00818053027444, 00818053027178, 00818053027185, 00818053027192, 00818053027208, 00818053027550, 00818053027581, 00818053027109, 00818053027147, 00818053027215, 00818053027222, 00818053027239, 00818053027246, 00818053023224, 00818053027321, 00818053027338, 00818053027383, 00818053027536, 00818053027574, 00818053027604, 00818053027611, 00818053027642, 00818053027659, 00818053027666, 00818053027277, 00818053027284, 00818053027154, 00818053027598, 00818053027376, 00818053027505, 00818053027703, 00818053027291, 00818053027352, 00818053027413, 00818053023989, 00818053023996

Source

Official record: FDA (Device enforcement) ↗

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