Boston Scientific Neuromodulation Corporation: Medical Device Recall in 2022 - (Recall #: Z-0230-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 12, 2022

Date Posted: November 23, 2022

Recall Number: Z-0230-2023

Event ID: 90915

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.

Status: Ongoing

Product Quantity: 175 devices

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated