The Prestige Coil System is a product family of embolic coils with associated delivery system components
Medical device recall Z-1042-2024. Published in FDA’s Enforcement Report on Feb 14, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 14, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 28 states named in where it went
- 2802 coils how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
2802 coils, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,995 characters
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…
FDA’s list runs to 20,583 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
28 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Florida
- Georgia
- Hawaii
- Illinois
- Kansas
- Massachusetts
- Maine
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Vermont
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 3, 2024.
- FDA classified it on Feb 8, 2024.
- FDA’s Enforcement Report published it on Feb 14, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BALT USA, LLC, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 20,583 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.