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RecallWatchMedical Device Safety
Class IIOngoingZ-2485-2025

Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM

Boston Scientific Neuromodulation CorporationValencia, CA, United StatesReported Sep 10, 2025 · 10 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    400 affected lots
    4028017440145632401172214011319840113255401133854011339140113482
    +392 more40106856400273852617697780027680030110MM101-981000884662000536402222974021359240199967401988094019524940186649401815054016630040157622401416574014177040136859401317984013203640112806401068704009356440080016400801114007649740070306400703074005200940045101400343394002733840027364400223984001829640018338400101284000403840004068400006473024469030178729299852302984951529849969296687122966871329578948295789492936026529360263293602642916055929160625287565012862719328627192286271942850159228501591285015932834437528344376283443772813312280027980034580026980027880026880028080026180027070008980025980026080025880025080031780031870008512MM101-98120088466200054340280071402459604022235540211234402114044021146340199117401992114018676040165937401575064015727940139759401400414013201140129328401141934011429040106757401069244009329940093565400800154008012440070323400517774004567340045706400446354004508040027314400273374002734640018297400183114001834440018360400101124001012640010144400040514000408140003228400006653024439630244397299852322998523329927752298500822985008529850083297884952966769929668637296686402962399229556093295479922954006929540067295400682939442629360815293612012936122029361221293611592936120029243822292440102924406729244068291704162916493528737193286273922862798528627195286209052854596028460945284609422846094428460941284609432844491528344378283443792828229528282296281331242813312528133123281230772805183628047778280477772804777927909032278446902781231627812317278090852780908427783073277830722778712327771035277357592770778827696311276572632765724427641430276195272762020027593135275940032757647627576376275589632755303627535575275312042750897827509115275091162692960426929605269281682681556026815561268076622665463226573432264897002637575880034080034980029780030380033980027380027280028280028380028480028570009070009180026580027180027480029580029870008770008880026380026470008680026270008414MM101-9814008846620005504022201840222380402112574018658840165998401134124011350340113583401136024011362040113621401136404010679640093429400519724004563240045657400273634001829940018362400006502926251830244395302448062998523129850095297035212954799129539391295233542939312829393129293944252917029629164945291649462875650228693439286280602862719928501594285015952833641228144010278684562773590027707785277077872753557626848047267999512661951026406210263668422632398480034280030080034180026680028780028680030480027580029916MM101-9816008846620005674029356940198619401864364008005340070342400519734001834529703520295755582778307127535578800267800343800277102-980000884662000574402778154027787440277890402779114027800440278100402781014027634440276407402764304027644440276525402765274027656640276587402766054027664640276663402766644027112440262838402629704026310840257898402584414025846240257952402580034025804740258067402581024025814040258141402563184025655440256555402565904025662740256645402566844025670640254134402541354025415340254211402542124025425640254257402542584025425940254274402543354025434940254350402543984025446440254465

What the firm is doing

On 06/06/2025, the firm sent an "Urgent Medical Device Removal - Immediate Action Required" Letter to customers inform them that, as a result of a comprehensive performance review of the Superion system and have determined that it is not meeting expected performance levels during the implantation procedure which includes breakage of the instrument (e.g., driver tip and insertion tool) and the device (e.g., spindle cap). Customer are instructed to: Physicians should stop all implants of the Superion Indirect Decompression System. Further distribution or use of any remaining affected product should cease immediately. This recall notification does not apply to Superion devices that have already been implanted and they can continue to remain in use. Boston Scientific is not recommending explant of successfully implanted Superion devices. 1. Continue to report all device-related incidents or quality concerns experienced with the Superion Indirect Decompression System to Boston Scientific. 2. Please segregate all Superion Indirect Decompression System product immediately and return it to Boston Scientific in accordance with the enclosed instructions. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. "Indicate the quantity of SINGLE units you will be returning for credit "If you have product that is listed in Attachment 1 (Affected Products) that is not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF "Return the RVTF via: Email: BSCFieldActionCenter@bsci.com, or Fax: BSC Field Action Center 1-763-415-7708 Public Contact - Renee Archie 508-683-4523 or email Renee.Archie@bsci.com

DistributionShow details

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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