CLASS II ONGOING Device recall · Reported 23 Nov 2022 · FDA Enforcement Report

Superion¿ Indirect Decompression System (IDS) recalled

Boston Scientific Neuromodulation is recalling Superion¿ Indirect Decompression System (IDS), distributed nationwide in the US. The recall was initiated on 12 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel (UPN): 101-9808 UDI-DI (GTIN) Code: 00884662000529 Lot/Batch Numbers: 26176977 Model (UPN): 101-9812 UDI-DI (GTIN) Code: 00884662000543 Lot/Batch Numbers: 26573432 26375758 26815560 26807662 26654632 26928168 26929605 26489700 Model (UPN): 101-9814 UDI-DI (GTIN) Code: 00884662000550 Lot/Batch Numbers: 26366842 26848047 26619510 26323984 26406210 26799951

Quantity recalled175 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0230-2023
FDA event ID: 90915
Recalling firm: Boston Scientific Neuromodulation, Valencia, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Oct 2022
FDA classified: 13 Nov 2022
Reported: 23 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Oct 2022	Recall initiated by company
13 Nov 2022	Classified by FDA	+32 days
23 Nov 2022	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm

Where it was distributed

U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Illinois Indiana Kansas Louisiana Michigan Minnesota Mississippi North Carolina North Dakota New Hampshire New Jersey

Questions about this recall

Is Superion¿ Indirect Decompression System (IDS) recalled?

Yes. Boston Scientific Neuromodulation recalled Superion¿ Indirect Decompression System (IDS) on 12 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0230-2023.

Why was it recalled?

Which lots are affected?

Model (UPN): 101-9808 UDI-DI (GTIN) Code: 00884662000529 Lot/Batch Numbers: 26176977 Model (UPN): 101-9812 UDI-DI (GTIN) Code: 00884662000543 Lot/Batch Numbers: 26573432 26375758 26815560 26807662 26654632 26928168 26929605 26489700 Model (UPN): 101-9814 UDI-DI (GTIN) Code: 00884662000550 Lot/Batch Numbers: 26366842 26848047 26619510 26323984 26406210 26799951

Where was it sold?

U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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