Class II U.S. Food and Drug Administration

Boston Scientific Neuromodulation Corporation Superion IDS Kit Superion Indirect recall: As a result of a comprehensive product performance review it was determine

Recall published 1+ years ago

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2485-2025
Published
September 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Neuromodulation Corporation
Product type
Medical devices
Units affected
70,516
Distribution
Nationwide
Made in
United States
Lot / code info
Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 ALL Lot/Batch Number: 40280174 40145632 40117221 40113198 40113255 40113385 40113391 40113482 40106856 40027385 26176977 800276 800301 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 ALL Lot/Batch Numbers: 40222297 40213592 40199967 40198809 40195249 40186649 40181505 40166300 40157622 40141657 40141770 40136859 40131798 40132036 40112806 40106870 40093564 40080016 40080111 40076497 40070306 40070307 40052009 40045101 40034339 40027338 40027364 40022398 40018296 40018338 40010128 40004038 40004068 40000647 30244690 30178729 29985230 29849515 29849969 29668712 29668713 29578948 29578949 29360265 29360263 29360264 29160559 29160625 28756501 28627193 28627192 28627194 28501592 28501591 28501593 28344375 28344376 28344377 28133122 800279 800345 800269 800278 800268 800280 800261 800270 700089 800259 800260 800258 800250 800317 800318 700085 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 ALL Lot/Batch Numbers: 40280071 40245960 40222355 40211234 40211404 40211463 40199117 40199211 40186760 40165937 40157506 40157279 40139759 40140041 40132011 40129328 40114193 40114290 40106757 40106924 40093299 40093565 40080015 40080124 40070323 40051777 40045673 40045706 40044635 40045080 40027314 40027337 40027346 40018297 40018311 40018344 40018360 40010112 40010126 40010144 40004051 40004081 40003228 40000665 30244396 30244397 29985232 29985233 29927752 29850082 29850085 29850083 29788495 29667699 29668637 29668640 29623992 29556093 29547992 29540069 29540067 29540068 29394426 29360815 29361201 29361220 29361221 29361159 29361200 29243822 29244010 29244067 29244068 29170416 29164935 28737193 28627392 28627985 28627195 28620905 28545960 28460945 28460942 28460944 28460941 28460943 28444915 28344378 28344379 28282295 28282296 28133124 28133125 28133123 28123077 28051836 28047778 28047777 28047779 27909032 27844690 27812316 27812317 27809085 27809084 27783073 27783072 27787123 27771035 27735759 27707788 27696311 27657263 27657244 27641430 27619527 27620200 27593135 27594003 27576476 27576376 27558963 27553036 27535575 27531204 27508978 27509115 27509116 26929604 26929605 26928168 26815560 26815561 26807662 26654632 26573432 26489700 26375758 800340 800349 800297 800303 800339 800273 800272 800282 800283 800284 800285 700090 700091 800265 800271 800274 800295 800298 700087 700088 800263 800264 700086 800262 700084 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 ALL Lot/Batch Numbers: 40222018 40222380 40211257 40186588 40165998 40113412 40113503 40113583 40113602 40113620 40113621 40113640 40106796 40093429 40051972 40045632 40045657 40027363 40018299 40018362 40000650 29262518 30244395 30244806 29985231 29850095 29703521 29547991 29539391 29523354 29393128 29393129 29394425 29170296 29164945 29164946 28756502 28693439 28628060 28627199 28501594 28501595 28336412 28144010 27868456 27735900 27707785 27707787 27535576 26848047 26799951 26619510 26406210 26366842 26323984 800342 800300 800341 800266 800287 800286 800304 800275 800299 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 ALL Lot/Batch Numbers: 40293569 40198619 40186436 40080053 40070342 40051973 40018345 29703520 29575558 27783071 27535578 800267 800343 800277 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 ALL Lot/Batch Numbers: 40277815 40277874 40277890 40277911 40278004 40278100 40278101 40276344 40276407 40276430 40276444 40276525 40276527 40276566 40276587 40276605 40276646 40276663 40276664 40271124 40262838 40262970 40263108 40257898 40258441 40258462 40257952 40258003 40258047 40258067 40258102 40258140 40258141 40256318 40256554 40256555 40256590 40256627 40256645 40256684 40256706 40254134 40254135 40254153 40254211 40254212 40254256 40254257 40254258 40254259 40254274 40254335 40254349 40254350 40254398 40254464 40254465 40254466 40254467…
UPC codes
00884662000529, 00884662000536, 00884662000543, 00884662000550, 00884662000567, 00884662000574, 00884662000611

Products covered by this recall

Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611 The Superion IDS Kit includes a set of proprietary instruments to deliver the Superion Implant in a minimally invasive manner. Instruments specifically designed for implanting the Superion Implant are sterile, single-use disposable instruments, consisting of a Dilator Assembly, Cannula Assembly, Interspinous Gauge, Inserter, Reamer, and Driver.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884662000529
  • 00884662000536
  • 00884662000543
  • 00884662000550
  • 00884662000567
  • 00884662000574
  • 00884662000611

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Boston Scientific Neuromodulation Corporation — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Boston Scientific Neuromodulation Corporation — 25155 Rye Canyon Loop, Valencia, CA, 91355-5004

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Boston Scientific Neuromodulation Corporation medical… recalled?

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device. As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884662000529, 00884662000536, 00884662000543. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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