SuperionRecalls & reported problems across all models

We found 5 models of Superion by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 1,488 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2018 and Jun 29, 2026 — classified as 408 injuries, 1,080 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (994 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Superion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 6, 2025Open, Classified

   As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

   Z-2485-2025 · Root cause: Device Design · names 5 of these models · Recall details · FDA record ↗

2. Oct 12, 2022Open, Classified

   Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.

   Z-0230-2023 · Root cause: Process change control · names 3 of these models · Recall details · FDA record ↗

Most reported Superion problems

Superion models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Superion™ 101-9812

  Prosthesis, Spinous Process Spacer/Plate
  2 recalls810 reports
• Superion™ 101-9810

  Prosthesis, Spinous Process Spacer/Plate
  1 recall356 reports
• Superion™ 101-9814

  Prosthesis, Spinous Process Spacer/Plate
  2 recalls295 reports
• Superion™ 101-9808

  Prosthesis, Spinous Process Spacer/Plate
  2 recalls4 reports
• Superion™ 101-9816

  Prosthesis, Spinous Process Spacer/Plate
  1 recall23 reports

Recent Superion adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Lack of Effect

  IT WAS REPORTED THAT THE PATIENT'S SUPERION INDIRECT DECOMPRESSION IMPLANT WAS EXPLANTED DUE TO INEFFECTIVELY TREATING THE PATIENT'S BACK PAIN. THE PATIENT HAS MADE A FULL RECOVERY FOLLOWING THE EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Back pain

  MAUDE report 25650394 ↗
• InjuryJun 29, 2026Migration; Lack of Effect

  IT WAS REPORTED THAT A PATIENT'S SUPERION INDIRECT DECOMPRESSION IMPLANT HAD MIGRATED, WHICH WAS CONFIRMED VIA FLUOROSCOPY. THE PATIENT HAD CONTINUED TO HAVE LOWER BACK PAIN, AND THE DEVICE WAS NOT EFFECTIVE TO TREAT THE PAIN. ACCORDING TO THE PHYSICIAN, IT WAS DIFFICULT TO DETERMINE IF THE MIGRATION OF THE IMPLANT CAUSED THE PAIN OR IF THE PAIN WAS UNRELATED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND THE PATIENT HAS MADE A FULL RECOVERY FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Back pain

  MAUDE report 25650388 ↗
• InjuryMay 18, 2026Difficult to Open or Close; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF A SUPERION INDIRECT DECOMPRESSION SYSTEM IN ORDER TO UNDERGO A DIFFERENT PROCEDURE. THE PATIENT STILL HAD PAIN AND WAS NOT CLEAR IF THE DEVICE WAS WORKING AS INTENDED. THE PHYSICIAN TRIED TO BACK OUT SCREW, BUT THE CAM LOBES WOULD NOT RETRACT. THE PHYSICIAN SAID THE PATIENT HAS SCAR TISSUE AROUND THE DEVICES AND THEY WOULD NOT COME OUT. THE PHYSICIAN REMAINED CAUTIOUS AND DECIDED TO LEAVE THEM IMPLANTED.

  Patient problems: Pain; Scar Tissue

  MAUDE report 25201476 ↗
• InjuryMay 18, 2026Difficult to Open or Close; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF A SUPERION INDIRECT DECOMPRESSION SYSTEM IN ORDER TO UNDERGO A DIFFERENT PROCEDURE. THE PATIENT STILL HAD PAIN AND WAS NOT CLEAR IF THE DEVICE WAS WORKING AS INTENDED. THE PHYSICIAN TRIED TO BACK OUT SCREW, BUT THE CAM LOBES WOULD NOT RETRACT. THE PHYSICIAN SAID THE PATIENT HAS SCAR TISSUE AROUND THE DEVICES AND THEY WOULD NOT COME OUT. THE PHYSICIAN REMAINED CAUTIOUS AND DECIDED TO LEAVE THEM IMPLANTED.

  Patient problems: Pain; Scar Tissue

  MAUDE report 25201470 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD THEIR SUPERION INTERSPINOUS SPACER DEVICE WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING PAIN WHILE WALKING. THE PAIN IS ATTRIBUTED TO THE SUPERION IMPLANT.

  Patient problems: Pain

  MAUDE report 24656216 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD THEIR SUPERION INTERSPINOUS SPACER DEVICE WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING PAIN WHILE WALKING. THE PAIN IS ATTRIBUTED TO THE SUPERION IMPLANT.

  Patient problems: Pain

  MAUDE report 24215477 ↗
• MalfunctionDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUPERION INDIRECT DECOMPRESSION SYSTEM PATIENT STATED THEIR "VF PROCEDURE FAILED." NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORT ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777687 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  IT WAS REPORTED THAT A PATIENT HAD THEIR SUPERION INTERSPINOUS SPACER DEVICE EXPLANTED FOR UNKNOWN REASONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547070 ↗
• InjuryNov 12, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SUPERION IMPLANT EXPERIENCED A LACK OF THERAPY FROM THE DEVICE, AS THEIR RECURRENT LATERAL RECESS STENOSIS SYMPTOMS IN THE LEGS HAD RETURNED. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE DEVICE, BUT THE EXPLANT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN CHOSE TO IMPLANT A NON-BSC DEVICE INSTEAD, WHICH RESOLVED THE PATIENT'S LEG SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538722 ↗
• MalfunctionNov 6, 2025Material Twisted/Bent; Material Twisted/Bent

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED A SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR AND SOME SCRAPES ON THE CAM LOBES. THE DAMAGE TO THE IMPLANT INDICATES FAILURE WAS LIKELY DUE TO DEPLOYMENT AGAINST RESISTANCE SUCH AS BONE AND/OR MANIPULATION OF THE POSITION OF THE DEVICE BY GEAR SHIFTING OF THE INSERTER. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND REVEAL NO ANOMALIES. THE INSTRUCTIONS FOR USE (IFU) STATES DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. SHOULD ANY RESISTANCE BE ENCOUNTERED DURING DEPLOYMENT OF THE SUPERION IMPLANT, IT MAY BE SUGGESTIVE OF INTERFERENCE BETWEEN THE IMPLANT AND BONY ANATOMY SUCH AS LAMINA, HYPERTROPHIC SPINOUS PROCESS, AND/OR SUBOPTIMAL IMPLANT POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493524 ↗
• MalfunctionOct 31, 2025Difficult to Open or Close; Difficult to Open or Close

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED A SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR AND SEVERE SCRAPES WERE OBSERVED ON ONE OF THE CAM LOBES. HOWEVER, THE IMPLANT FUNCTIONED ACCEPTABLY DURING THE FUNCTIONAL TEST. THE DAMAGE TO THE IMPLANT INDICATES FAILURE WAS LIKELY DUE TO DEPLOYMENT AGAINST RESISTANCE SUCH AS BONE. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE (IFU) STATES DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IT STATES THAT IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, ROTATE THE DRIVER COUNTERCLOCKWISE UNTIL A POSITIVE STOP IS REACHED AND WITHDRAW DORSALLY TO COLLAPSE THE CAM LOBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441610 ↗
• MalfunctionOct 31, 2025Material Twisted/Bent; Material Twisted/Bent

  DEVICE ANALYSIS OF THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT, ALTHOUGH THE IMPLANT DEPLOYED FULLY AND SUCCESSFULLY, BOTH THE SUPERIOR AND INFERIOR CAM LOBES SHOWED RESISTANCE TO ROTATING FREELY AROUND THE PIVOT PIN. MICROSCOPIC EXAMINATION INDICATED SEVERE DAMAGE TO THE ACTUATOR AT ITS MATING SURFACE. THE PATIENTS REPORTEDLY THICK SPINOUS PROCESS AND LIMITED SPACE LIKELY CREATED CONDITIONS THAT LED THE USER TO APPLY EXCESSIVE FORCE ON THE INSERTER AND IMPLANT. THIS UNDUE FORCE IS SUPPORTED BY THE OBSERVED ACTUATOR DAMAGE. UNDER SUCH CIRCUMSTANCES, REPEATED DEPLOYMENT ATTEMPTS CAN CAUSE SIGNIFICANT WEAR ON THE PIVOT PINS, ULTIMATELY RESULTING IN CAM LOBE MALFUNCTION. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND THE INSTRUCTIONS FOR USE (IFU) STATES DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IT STATES THAT IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, ROTATE THE DRIVER COUNTERCLOCKWISE UNTIL A POSITIVE STOP IS REACHED AND WITHDRAW DORSALLY TO COLLAPSE THE CAM LOBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437661 ↗
• MalfunctionOct 31, 2025Material Twisted/Bent; Material Twisted/Bent

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THE RIGHT WING OF THE SUPERIOR CAM LOBE WAS SLIGHTLY BENT AWAY FROM THE MEDIAN LINE. THE IMPLANT DID NOT FUNCTION ACCEPTABLY UPON FUNCTIONAL TESTING SINCE THE IMPLANT DEPLOYED WITH EXCESSIVE RESISTANCE AND ONE OF THE CAM LOBES WOULD NOT RETRACT WITHOUT ADDITIONAL EFFORT. THE DAMAGE TO IMPLANT INDICATES THE OBSERVED DAMAGE WAS LIKELY DUE TO FORCED DEPLOYMENT AGAINST A RIGID OBSTRUCTION SUCH AS THE SPINOUS PROCESS. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND THE INSTRUCTIONS FOR USE (IFU) STATES DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433383 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THE DEVICE DEPLOYED WITH RESISTANCE AND THE CAM-LOBES WOULD NOT RETRACT WITHOUT AN ADDITIONAL EFFORT. THIS DAMAGE IS LIKELY DUE TO THE USER EXERTING UNDUE FORCE ON THE IMPLANT WHICH RESULTED IN WEAR OF THE PIVOT PINS WHICH CAUSED THE MALFUNCTION OF THE CAM LOBES. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND THE INSTRUCTIONS FOR USE (IFU) STATES DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433380 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING AN IMPLANT PROCEDURE. AS THE PHYSICIAN ATTEMPTED TO TAMP DOWN THE SPACER TOWARD THE END OF THE PROCEDURE, THE BOTTOM SET OF CAM LOBES BROKE OFF. IT WAS NOTED THERE MAY HAVE BEEN OSTEOPHYTES CAUSING RESISTANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433374 ↗

Other Boston Scientific Neuromodulation Corporation products

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