Precision ™ SC-4230Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729767572), received between Dec 28, 2021 and May 26, 2026 — classified as 3 injuries, 2 malfunctions.

17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT LOST MOTOR FUNCTION IN LEFT LIMB WHEN PASSING ELEVATOR WAS INSERTED. PATIENTS MOTORS SLOWLY IMPROVED ONCE REMOVING THE PASSING ELEVATOR. MOTORED RETURNED TO NORMAL BUT THE PHYSICIAN DECIDED NOT TO MOVE FORWARD WITH THE IMPLANT FOR THE TRIAL. THE PRODUCT WAS DISCARDED PER HOSPITAL POLICY.

  Patient problems: Insufficient Information

  MAUDE report 25295128 ↗
• MalfunctionFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A LOSS OF MOTOR CONTROL OF THE RIGHT LEG FOLLOWING THE USE OF THE PASSING ELEVATOR DURING THE SCS IMPLANT PROCEDURE. ADDITIONALLY, THE PATIENTS BLOOD PRESSURE HAD INCREASED INTRAOPERATIVELY. THEREFORE, THE PHYSICIAN ABORTED THE SCS IMPLANT PROCEDURE AND PROCEEDED WITH A LAMINECTOMY WITH NO DEVICES IMPLANTED. THE PATIENTS SENSORY AND MOTOR CONTROL RETURNED TO BASELINE POSTOPERATIVELY AND THE PATIENT WAS ABLE TO MOVE ALL EXTREMITIES NORMALLY.

  Patient problems: High Blood Pressure/ Hypertension; Paralysis

  MAUDE report 21405280 ↗
• MalfunctionApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE NEURO MONITORING NOTICED THAT THE PATIENTS MOTORS DECREASED BELOW FIFTY PERCENT AND WENT BACK UP TO JUST BELOW NORMAL. THE PHYSICIAN BELIEVED THIS HAPPENED WHEN THE PASSING ELEVATOR WAS PLACED. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PASSING ELEVATOR WAS DISCARDED BY THE HOSPITAL.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 16661829 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATOR IMPLANT PROCEDURE THE PATIENT HAD EXCESSIVE BLEEDING AND WAS HYPERTENSIVE. THE PATIENTS MOTORS WERE LOST AFTER THE PASSING ELEVATOR WAS INSERTED. WITH THE ISSUES PRESENTED THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. WHILE CLOSING THE INCISION THE PATIENTS LEFT FOOT MOTORS CAME BACK. THE PHYSICIAN DOES NOT BELIEVE HE APPLIED ENOUGH PRESSURE TO CAUSE A LOSS IN MOTORS. THE PATIENT WAS ABLE TO REGAIN RESPONSE IN ALL EXTREMITIES AND THE PATIENT WAS STILL IN THE HOSPITAL GETTING READY FOR REHABILITATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Paralysis

  MAUDE report 15924703 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PATIENTS MOTORS FOR THE LOWER EXTREMITIES WERE NO LONGER RESPONDING. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AFTER MULTIPLE TESTS WERE PERFORMED. THE PHYSICIAN BELIEVED THAT THIS WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE OF THE NEUROLOGICAL SYMPTOM WAS UNKNOWN. THE PATIENT WAS RECOVERING AND HAD LEFT LEG WEAKNESS POST-OPERATIVELY. THE USED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 13091889 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.

• Z-2879-2026 · Jun 17, 2026 · Open, Classified
  INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
• Z-2404-2026 · Apr 29, 2026 · Open, Classified
  Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
• Z-2617-2024 · Jul 17, 2024 · Open, Classified
  WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
• Z-2120-2020 · Apr 24, 2019 · Terminated
  Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
• Z-2121-2020 · Apr 24, 2019 · Terminated
  LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
• Z-2123-2020 · Apr 24, 2019 · Terminated
  Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
• Z-2122-2020 · Apr 24, 2019 · Terminated
  The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
• Z-2119-2020 · Apr 24, 2019 · Terminated
  ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
• Z-2124-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
• Z-1409-2010 · Mar 19, 2010 · Terminated
  Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Z-0271-2009 · Sep 22, 2008 · Terminated
  Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
• Z-1441-2012 · Apr 22, 2008 · Terminated
  OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
• Z-0960-2008 · Oct 5, 2007 · Terminated
  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
• Z-0055-2008 · Aug 3, 2007 · Terminated
  Precision Implantable Pulse Generator (IPG), Model Number SC-110
• Z-0700-2007 · Jan 30, 2007 · Terminated
  The Precision Implantable Pulse Generator, Model Number SC-1110

…and 2 more.