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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92181

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Neuromodulation Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1972-2023
Recall number
Z-1972-2023
Initiated
May 12, 2023
Classification
Class II
Status
Ongoing
Quantity
21,533

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
metal fragments

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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