Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published May 12, 2023

Boston Scientific Driver Instrument Recall: Risk of Metal Fragments from Tip Breaks

Boston Scientific recalls Driver Instrument (REF: 102-9800) used in Superion Indirect Decompression System. Excessive force during implant may cause tip breaks, leading to metal fragments that could cause injury if not removed. MRI scans are unsafe if fragments remain.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1972-2023Medical deviceBoston Scientific ›
Take action

Contact the company

Recalling firmBoston Scientific Neuromodulation Corporation25155 Rye Canyon Loop · Valencia, CA 91355-5004
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling Driver Instruments (REF: 102-9800) used with the Superion Indirect Decompression System. Excessive force during implant surgery can cause the instrument to break, potentially leaving metal fragments inside the body. If fragments remain, MRI scans could cause injury. Read more at govinfonow.com/recall/58318-boston-scientific-driver-instrument-recall-risk-of-metal-fragments-from.

Source Summary by GovInfoNow · govinfonow.com/recall/58318-boston-scientific-driver-instrument-recall-risk-of-metal-fragments-from · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1972-2023

Cite this page

“Boston Scientific Driver Instrument Recall: Risk of Metal Fragments from Tip Breaks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58318-boston-scientific-driver-instrument-recall-risk-of-metal-fragments-from. Based on FDA recall #Z-1972-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1972-2023%22&limit=1).

The FDA announced on May 12, 2023, that Boston Scientific Neuromodulation Corporation is recalling the Driver Instrument (REF: 102-9800) for the Superion Indirect Decompression System. The hazard involves potential driver instrument tip breaks during implant procedures.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Driver Instrument, part of the Superion Indirect Decompression System
  • REF: 102-9800
  • UPN: 102-9800
  • UDI-DI: 00884662000574
  • Lots: All Lots

The hazard

According to the FDA, excessive force during the implant procedure may cause driver instrument tip breaks, resulting in metal fragments remaining in the implant location. The record states that if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.

Context

GovInfoNow's records show Boston Scientific Neuromodulation Corporation has 12 other recalls on record since April 24, 2019. Other recent recalls include the INFINION CX Lead Kits Recall (June 17, 2026), TCN Electrodes May Not Meet Performance Levels recall (April 29, 2026), and SC-4318 Clik X Anchor Recall (April 29, 2026). Additional recent recalls of similar products include the Imager II Angiographic Catheters Recall (August 24, 2026) and the ENROUTE Transcarotid Neuroprotection System Recalls (July 9, 2026).

How to tell if you have this one

Check for the reference number 102-9800 on the Driver Instrument. The product was sold with Superion Indirect Decompression System IFU, Superion IDS Kit IFU, and Surgical Technique Manual.

  • Brand
    Boston Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check for Tip Breaks

    Inspect the Driver Instrument for cracks or broken tips, which may indicate a break from excessive force during implant.

  2. Contact Your Surgeon

    Ask your surgeon if you received the recalled Driver Instrument (REF: 102-9800) during implant surgery.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 47 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: May 12, 202312. FDA classified it Class II: Jun 15, 202323. Published in FDA’s Enforcement Report: Jun 21, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1972-2023 (May 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1972-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA