Z-0230-2023Class II

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

Name: Z-0230-2023 Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814...
Creator: Boston Scientific Neuromodulation Corporation
Published: 2022-10-12
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2022-10-12 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Neuromodulation Corporation began a recall of Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm on 2022-10-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0230-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-12
Posted: 2022-11-14
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Product code: NQO Prosthesis, Spinous Process Spacer/Plate
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.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On 10/12/2022, the firm, Boston Scientific, sent an "Urgent: Medical Device Recall" letter via FedEx to customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: -Review their facility's device inventory: Segregate and return any unused Superion IDS devices from the affected subset to Boston Scientific. Complete and return account-specific Reply Verification Tracking Form via Email: [email protected] or Fax to: Field Action Center at 1-763-415-7708. -Patient follow-up: Discuss this advisory with their patient(s) who are implanted with an affected device. Promptly investigate any reported pain and/or discomfort, or any suspected indication of migration of the Superion IDS implant, which may suggest a potential spindle cap weld break. If an affected device remains implanted in their patient, and successful deployment and/or device structural integrity is questioned, consider confirming via imaging. -If a spindle cap weld break is confirmed post-implant: Assess the clinical benefits versus risks associated with explanting an affected Superion IDS from their patient. Note that the Superion IDS Inserter tool would be unable to engage a non-intact device for explant. Medical judgement is required for determining the appropriate surgical method for explant in such cases. -Records: For each patient with an affected Superion IDS, append their medical record with a copy of this letter to maintain awareness of this topic for the remaining service life of the device. Should any revision/replacement occur, please inform Boston Scientific with relevant clinical information. For additional information or questions - contact the local Boston Scientific representative, or the Firm's Public Contact, Director, Global Corporate Communications at 415-730-2310 or [email protected].
Quantity in commerce: 175 devices
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0230-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0230-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-13

Product code NQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)