Z-1972-2023Class II

Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion...

Name: Z-1972-2023 Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion...
Creator: Boston Scientific Neuromodulation Corporation
Published: 2023-05-12
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2023-05-12 / Open, Classified / root cause: labeling and UDI

FDA source

Boston Scientific Neuromodulation Corporation began a recall of Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS... on 2023-05-12. FDA classified it as Class II and gives the reason as "Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1972-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-12
Posted: 2023-06-15
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Product code: NQO Prosthesis, Spinous Process Spacer/Plate
Reason for recall: Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 05/12/23, correction notices were mailed to physicians/surgeons, hospitals, healthcare professionals who were advised the following: IFU advises against forced deployment, as it could result in device breakage. Correction notice advises to review of the IFUs/Surgical Technique Manual. Avoid application of excessive force, use only two or three fingers when performing final tightening during device deployment). Inspect Driver instrument prior to/following use; if Driver tip break is noted: Retrieve metal fragment(s), consider performing imaging. Missing/bent teeth prevents Driver engagement with implant and requires exchange for a new/replacement Driver instrument to complete successful deployment. If metal fragment(s) are not successfully removed: MRI scans are NOT advised, Append the patient s medical record with a copy of this letter to maintain awareness of metal fragment(s) remaining in situ for the remaining service life of the device. Consider alternative imaging for patients with metal fragment(s) remaining in situ, e.g., X-ray/ultrasound/CT scan. Distributors asked to notify all customers that have been shipped/sold affected product. Complete/return acknowledgement form to [email protected] or Fax to: Field Action Center (1-866-213-1806). Driver tip breakage can be identified via an audible click, a loss of tactile resistance during the implant procedure, and/or visual detection following removal of the Driver instrument from the inserter tool and subsequent inspection. Adverse events or quality concerns should be reported to [email protected]. If you have any question, contact Senior Management Quality: at 651-581-0761 or email: [email protected] Firm is updating IFU to advise against MRI scanning for patients with unretrieved metal fragments. A separate letter was sent to health care professions providing them with a patient letter. Patient letter states firm recommends patients discuss this letter with t
Quantity in commerce: 21,533
Distribution: US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND
Product codes and lots: Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots. Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1972-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1972-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-15

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)