FDAFDA · Food and drugs·Recall number Z-1042-2024
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 and a pusher assembly. There are a total of 81 Prestige coil models. Vascular Embolization Device Prestige Coil Model Numbers and Product description: PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES1137COM18 Prestige Coil 11mm x 37cm Complex-18 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack PRES0210CXP10 Prestige Coil 2mm x 10cm Complex-10 Xtra Pack PRES0258CXP10 Prestige Coil 2.5mm x 8cm Complex-10 Xtra Pack PRES0417CPK10 Prestige Coil 4mm x 17cm Complex-10 Xtra Pack PRES0520CPK10 Prestige Coil 5mm x 20cm Complex-10 Xtra Pack PRES0615CPK10 Prestige Coil 6mm x 15cm Complex-10 Xtra Pack PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES2525HXPPL Prestige Coil 2.5mm x 2.5cm Prestige Plus Helical Xtra Pac PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CRG10 Prestige Coil 4mm x 13cm Complex 10 Regular PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0306HPK10 Prestige Coil 3mm x 6cm Helical-10 Pack PRES0310HPK10 Prestige Coil 3mm x 10cm Helical-10 Pack PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack PRES0930H
Published February 14, 2024 · Recall initiated: January 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BALT USA, LLC
- Distributor
- 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.
- Lot
- 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 F201000333 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack 00818053027215 F201000334 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack 00818053027222 F201000335 PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack 00818053027239 F201000336 PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack 00818053027246 F201000450 PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 00818053023224 F201000451 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac 00818053027321 F201000452 PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac 00818053027338 F201000453 PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac 00818053027383 F201000454 PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack 00818053027536 F201000455 PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack 00818053027574 F201000516 PRES0210CXP10 Prestige Coil 2mm x 10cm Complex-10 Xtra Pack 00818053027604 F201000517 PRES0258CXP10 Prestige Coil 2.5mm x 8cm Complex-10 Xtra Pack 00818053027611 F201000518 PRES0417CPK10 Prestige Coil 4mm x 17cm Complex-10 Xtra Pack 00818053027642 F201000520 PRES0520CPK10 Prestige Coil 5mm x 20cm Complex-10 Xtra Pack 00818053027659 F201000521 PRES0615CPK10 Prestige Coil 6mm x 15cm Complex-10 Xtra Pack 00818053027666 F201000522 PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac 00818053027277 F201000523 PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac 00818053027284 F201000524 PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack 00818053027451 F201000526 PRES2525HXPPL Prestige Coil 2.5mm x 2.5cm Prestige Plus Helical Xtra Pac 00818053027154 F201000527 PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack 00818053027598 F201000564 PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac 00818053027376 F201000571 PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack 00818053027505 F201000572 PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack 00818053027536 F201000575 PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac 00818053027284 F201000788 PRES0413CRG10 Prestige Coil 4mm x 13cm Complex 10 Regular 00818053027703 F201000789 PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac 00818053027291 F201000790 PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac 00818053027352 F201000791 PRES03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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