Entrada ™ SC-4220-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729950684), received between Jul 11, 2018 and Jan 6, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (6 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE PERMANENT LEAD IMPLANT, A WET TAP OCCURRED. THE SYMPTOM REPORTED WAS A LIGHT HEADACHE. THE PATIENT WAS ALREADY SEDATED AT THE TIME. THE PROCEDURE WAS STOPPED, AND THE DEVICE WAS EXPLANTED BECAUSE THE LEADS COULD NOT BE CORRECTLY POSITIONED WITHIN THE EPIDURAL SPACE. THE PATIENT IS RECOVERING POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED AS IT WAS DISPOSED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 23973403 ↗
• InjurySep 27, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATION (SCS) PERMANENT IMPLANT PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO ACCESS PATIENTS EPIDURAL SPACE. THE PHYSICIAN IS NOT ENTIRELY CERTAIN BUT BELIEVES HE MAY HAVE PARTIALLY ENTERED THE DURA CAUSING A SMALL CEREBROSPINAL FLUID LEAKAGE (CSF LEAK). THE PHYSICIAN PROCEEDED THE REST OF THE CASE AND AT THE END BEFORE CLOSING DID A BLOOD PATCH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 20326058 ↗
• InjurySep 5, 2024Adverse 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 VOMITING AND HEADACHES FOLLOWING A REVISION PROCEDURE (REPORTED MFR# 3006630150-2024-05904). IT WAS NOTED THAT THE ENTRADA NEEDLE USED DURING THAT PROCEDURE APPEARED TO BE VERY SHARP, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A SUSPECTED DURAL TEAR THAT CAUSED CEREBROSPINAL FLUID (CSF) LEAKAGE. A BLOOD PATCH WAS DONE TO HELP HEAL THE TEAR, THE PATIENT'S THE SYMPTOMS SUBSIDED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Vomiting

  MAUDE report 20152954 ↗
• InjuryFeb 16, 2023Adverse 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 CEREBRAL SPINAL FLUID LEAK DURING THE IMPLANT PROCEDURE. THE PATIENT UNDERWENT A BLOOD PATCH AND THE PATIENT WAS DOING FINE POST-OPERATIVELY.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 16389904 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS ENTERING USING THE NEEDLE AND HIT A NERVE ROOT ON THE LEFT SIDE CAUSING THE PATIENT TO LOSE SENSATION AND MOTOR FUNCTION IN HER LEFT LEG THEREFORE THE TRIAL WAS ABORTED. THE PATIENT REGAINED FULL SENSATION AND MOTOR FUNCTION IN THE LEFT LEG. IT WAS ALSO NOTED THAT STRENGTH AND NUMBNESS HAD SIGNIFICANTLY IMPROVED BUT PATIENT WAS STILL EXPERIENCING PAIN IN THE LEG AND ADMITTED HERSELF INTO THE HOSPITAL. THE ENTRADA NEEDLE WAS DISCARDED BY MEDICAL FACILITY.

  Patient problems: Nerve Damage; Numbness; Pain; Paralysis

  MAUDE report 13865602 ↗
• InjuryAug 11, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL SPINAL FLUID LEAK DURING A PREVIOUS REVISION PROCEDURE. THE PHYSICIAN WAS ABLE TO USE SURGICAL GLUE TO REPAIR THE PUNCTURE. THE PATIENT WAS DOING FINE POST-OPERATIVELY BUT DID DEVELOP A HEADACHE AND INTENSE PAIN. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS FOR THE DURA PUNCTURE. THE DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; No Code Available; Pain

  MAUDE report 10392094 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT DURING AN INITIAL IMPLANT PROCEDURE THE PHYSICIAN NOTICED CSF LEAKAGE. THE PROCEDURE WAS ABORTED AND A BLOOD PATCH WAS PERFORMED. THE PATIENT WAS REPORTEDLY DOING WELL.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 9345726 ↗
• InjuryNov 1, 2019Use of Device Problem; Use of Device Problem

  A REPORT WAS RECEIVED THAT DURING AN IMPLANT PROCEDURE, THE PATIENT STARTED TO EXPERIENCE DIURNAL HEADACHES. THE PATIENT WAS IMPLANTED WITHOUT FURTHER PROBLEMS. SEVERAL DAYS LATER THE PATIENT DID NOT SHOW UP FOR HIS PROGRAMMING SESSION. THE DOCTOR WAS INFORMED THAT THE PATIENT WAS HOSPITALIZED FOR THE DIURNAL HEADACHES AND WAS GIVEN A BLOOD PATCH. THE CAUSE OF THE HEADACHES WERE DUE TO THE USE OF THE ENTRADA NEEDLE DURING THE IMPLANT PROCEDURE AND TECHNIQUE OF THE PHYSICIAN.

  Patient problems: Headache; No Code Available

  MAUDE report 9267169 ↗
• InjuryOct 22, 2019Use of Device Problem; Use of Device Problem

  A REPORT WAS RECEIVED THAT DURING A PERMANENT IMPLANT PROCEDURE THE PATIENT EXPERIENCED A DURAL PUNCTURE RESULTING IN A SIGNIFICANT LOSS OF SPINAL FLUID. A BLOOD PATCH WAS ADMINISTERED AND THE PROCEDURE WAS ABORTED. THE PATIENT IS RECOVERING, AND THE EVENT RESOLVED THE SAME DAY. THE PHYSICIAN ASSESSED THAT THE NON-SERIOUS ADVERSE EVENT WAS PROCEDURE RELATED AND NOT DEVICE OR STIMULATION RELATED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 9218952 ↗
• InjuryOct 12, 2018Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  A REPORT WAS RECEIVED THAT DURING AN IMPLANT PROCEDURE THE PATIENT HAD AN ABNORMAL EXCESSIVE BLEEDING AT THE INSERTION SITE. THE PHYSICIAN BELIEVED IT WAS DUE TO THE SHARPNESS OF THE NEEDLE. THE PHYSICIAN APPLIED PRESSURE AND FLOW SEAL TO STOPPED THE BLEEDING. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7963072 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT DURING A PERM IMPLANT THE PATIENT HAD A CEREBROSPINAL FLUID LEAKAGE (CSF LEAK) ON BOTH NEEDLE PLACEMENTS. THE PHYSICIAN WAS NOT ABLE TO PUT IN THE LEAD DUE TO CSF LEAK. THE PHYSICIAN DID A BLOOD PATCH AND IT WAS UNKNOWN IF THERE WAS ANY OTHER MEDICATION GIVEN. THE CASE WAS ABORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7679390 ↗

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-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-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-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-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-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.