Vertiflex™ VIP 140-9800Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00884662000611), received between Feb 28, 2020 and May 4, 2026 — classified as 18 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Disconnect” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (P140004); 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.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Nonstandard Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICES WERE ANALYZED AND VISUAL INSPECTION REVEALED THAT INTERIOR STERILE PACKAGING WAS DAMAGED. HOWEVER, THE INSTRUMENTS WITHIN THE KIT WERE SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION, AND NO ANOMALIES OR DEFECTS COULD BE CONFIRMED. THEREFORE, THE PROBABLE CAUSE SELECTED IS CAUSE TRACED TO TRANSPORT/STORAGE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. ADDITIONALLY, STERILITY CAN ONLY BE ASSURED IF THE PACKAGE IS INTACT. DO NOT USE THIS DEVICE IF THE PACKAGE HAS BEEN OPENED OR DAMAGED. ONCE OPENED, DO NOT ATTEMPT TO REUSE OR RESTERILIZE THIS PRODUCT. STORE IN A SUITABLE, CLEAN AREA UNTIL READY FOR USE. USE STERILE PACKAGED SUPERION IDS INSTRUMENTS PRIOR TO THE EXPIRATION DATE LISTED ON THE PACKAGE" AS WELL AS "INSPECT STERILE PACKAGED SUPERION IDS INSTRUMENTS AND PACKAGING TO VERIFY THAT NO DAMAGE HAS OCCURRED AS A RESULT OF SHIPP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069019 ↗
• MalfunctionJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SUPERION INDIRECT DECOMPRESSION SYSTEM IMPLANT PROCEDURE THE PATIENT WAS PUT UNDER GENERAL ANESTHESIA. FOLLOWING THIS, THE PATIENTS HEART RATE DROPPED CAUSING THE PROCEDURE TO BE ABORTED. THE PATIENT WAS DOING WELL POST EVENT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Bradycardia

  MAUDE report 21114383 ↗
• MalfunctionApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SUPERION INDIRECT DECOMPRESSION SYSTEM IMPLANT PROCEDURE THE PATIENT EXPERIENCED AIRWAY OBSTRUCTION FORCING THE PROCEDURE TO BE ABANDONED SO THEY COULD PLACE THE PATIENT ON HIS BACK TO CLEAR THE AIRWAY. THE PATIENT WAS DOING WELL POST ABANDONED PROCEDURE. THE PHYSICIAN INDICATED THIS PATIENT SUFFERS FROM SEVERE SLEEP APNEA WHICH RESULTED IN THE AIRWAY OBSTRUCTION DURING THE PROCEDURE.

  Patient problems: Airway Obstruction; Cerebrospinal Fluid Leakage; Insufficient Information

  MAUDE report 19041477 ↗
• InjuryDec 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S HEART RATE AND BLOOD PRESSURE DROPPED AFTER BEING SEDATED DURING THE PROCEDURE TO IMPLANT AN INDIRECT DECOMPRESSION SPACER. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS TAKEN TO RECOVERY FOR OBSERVATION. THE PATIENT FULLY RECOVERED AND WAS RELEASED FROM THE HOSPITAL.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 18253206 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN BECAME CONCERNED WITH THE PATIENT'S VITALS AFTER BEING SEDATED WHEN THE PATIENT WAS FLIPPED OVER TO THEIR STOMACH PRIOR TO MAKING THE INCISION. THE PHYSICIAN DECIDED NOT TO CONTINUE WITH THE PROCEDURE, AND THE PATIENT WAS STABLE IMMEDIATELY AFTER.

  Patient problems: Insufficient Information

  MAUDE report 18120270 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE THE PATIENT SEEMED TO BLEED EXCESSIVELY. THE PHYSICIAN WAS ABLE TO GET THE BLEEDING UNDER CONTROL AND PROCEEDED TO MAKE AN INCISION INTO THE SUPER SPINOUS LIGAMENT. AT THAT POINT, THE PHYSICIAN HAD TROUBLE CONTROLLING THE EXCESSIVE BLEEDING. PRIOR TO THE USE OF ANY SUPERION INSTRUMENT, THE PHYSICIAN DECIDED TO ABORT THE IMPLANT PROCEDURE. CAUTERY AND FLO SEAL WERE USED TO CONTROL THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16919440 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HER BACK AND LEGS APPROXIMATELY EIGHT MONTHS FOLLOWING HER SUPERION INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE. THE PHYSICIAN ASSESSED THAT THE TOP OF THE CAM LOBES HAD MIGRATED POSTERIORLY WAY FROM THE VERTEBRAL BODY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND IS DOING WELL POST-OPERATIVELY.

  Patient problems: Pain

  MAUDE report 16567444 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE, WHEN THE DILATOR WAS INSERTED BETWEEN THE L2-L3 LUMBAR VERTEBRAE, THE SPINOUS PROCESS WAS FRACTURED AT THE L3 LUMBAR VERTEBRA. THE IMPLANT PROCEDURE WAS ABORTED AND THE INCISION WAS CLOSED. THERE WERE NO REPORTED ISSUES POSTOPERATIVELY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: Vertebral Fracture

  MAUDE report 16207273 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN PREPARATION FOR THE PROCEDURE THE PATIENT WAS PLACED ON THE OPERATING TABLE FACE DOWN AND LOCAL ANESTHESIA WAS ADMINISTERED. THE PATIENT EXPERIENCED DIFFICULTY BREATHING. THE PATIENT WAS TURNED OVER, PLACED ON HIS BACK AND GIVEN OXYGEN. THE PROCEDURE WAS THEN ABORTED.

  Patient problems: Respiratory Insufficiency

  MAUDE report 15602610 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE BACK PAIN FOLLOWING A SUPERION INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WHERE AN X-RAY WAS TAKEN WHICH REVEALED THAT THE PATIENT HAD A PROCESS FRACTURE AT THE LEVEL OF THE SPACER IMPLANT. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 14518743 ↗
• InjuryApr 27, 2022Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE DURING A SUPERION INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE, THE DEVICE MALFUNCTIONED AND THE DILATOR ADVANCED TOO FAR ANTERIOR. THE PATIENT EXPERIENCED A DURA INJURY AT L4-L5 OF THE LUMBAR VERTEBRAE AND HAD A CEREBROSPINAL FLUID (CSF) LEAK. THE PHYSICIAN ADMINISTERED A BLOOD PATCH AND THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS DOING WELL POST OPERATIVELY.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14216655 ↗
• MalfunctionMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SUPERION IMPLANT PROCEDURE THE PATIENT WAS UNDER MAC, MINIMAL ANESTHETIC CONCENTRATION. THE PHYSICIAN MADE THE INITIAL INCISION, PLACED THE INSERTER DILATOR AND THE PATIENT BEGAN TO MOVE. THE REMOVED THE DILATOR, THE PATIENT CONTINUED TO MOVE AND WOULD NOT COOPERATE WITH THE ANESTHESIA TEAM. THE PHYSICIAN DECIDED TO CLOSE THE INITIAL INCISION AND ABORTED THE PROCEDURE. THE PATIENT IS DOING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13878120 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S OXYGEN SATURATION LEVELS BEGAN TO DROP DURING A PROCEDURE TO IMPLANT THE SUPERION INDIRECT DECOMPRESSION SPACER. THE PATIENT HAD BEEN SEDATED, AND AN INCISION HAD BEEN MADE OVER THE L4-L5 INTERSPACE; THE PHYSICIAN HAD POSITIONED DILATOR 1 PROPERLY AT THE TIME THE PATIENT'S OXYGEN LEVELS BEGAN TO DROP, AND THE ANESTHESIOLOGIST ASSESSED THAT THE PROCEDURE NEEDED TO BE ABORTED. THE INCISION WAS PACKED, AND ONCE THE PATIENT WAS REPOSITIONED ON THEIR BACK, OXYGEN WAS FORCED VIA ARTIFICIAL MANUAL BREATHING UNIT (AMBU) BAG. THE PATIENT'S OXYGEN LEVELS WERE NORMALIZED AND THE PATIENT WAS CONSCIOUS.

  Patient problems: Hypoxia; Respiratory Insufficiency

  MAUDE report 13596432 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT THE SUPERION INDIRECT DECOMPRESSION SPACER AT THE LEVEL OF L4-L5, THERE WAS FLUID RETURN WHEN REPOSITIONING DILATOR ONE RESULTING IN A "WET TAP". THE PHYSICIAN THEN PERFORMED A BLOOD PATCH, AND HAD THE PATIENT LAY FLAT FOR ONE HOUR WHILE IN RECOVERY. THE PATIENT DID WELL POST-OPERATIVELY AND DID NOT EXPERIENCE A HEADACHE FOLLOWING THE PROCEDURE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12763836 ↗
• MalfunctionOct 4, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE FOR THE SUPERION INDIRECT DECOMPRESSION SPACER, THE INSERTER AN INSTRUMENT USED TO IMPLANT THE SPACER, WAS BENT. THE PROCEDURE WAS CANCELLED AFTER THE PATIENT HAD BEEN SEDATED. THE INSERTER WAS RETAINED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572932 ↗
• InjuryJul 14, 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 PATIENT WAS POSITIONED ON THEIR STOMACH AND INCISION WAS MADE. THEN THE DILATOR WAS INSERTED AND THE PATIENT STARTED TO HAVE DIFFICULTIES WITH THEIR OXYGEN AND SATURATION LEVELS. THE PROCEDURE WAS ABORTED. THE PATIENT WAS FLIPPED OVER AND CHEST COMPRESSIONS WERE DONE DUE TO THE PATIENT NOT BREATHING. EMERGENCY MEDICAL SERVICES WERE CALLED TO ATTEND TO THE PATIENT AND AFTER THE PATIENT'S BLOOD PRESSURE AND OXYGEN SATURATION STABILIZED, THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT WAS IN STABLE CONDITION AT THE HOSPITAL. IT WAS NOTED THAT THE PATIENT HAS PRE-EXISTING BREATHING ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 12169602 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT BEGAN HAVING RESPIRATORY ISSUES DURING THE PROCEDURE TO IMPLANT THE DEVICE. IT WAS ASSESSED THAT THE PATIENT HAD A REACTION TO THE ANESTHESIA. THE PROCEDURE WAS ABORTED AND THE PATIENT WILL BE SCHEDULED AT A FUTURE DATE. PATIENT IS FINE POST-OPERATIVELY.

  Patient problems: No Code Available; Respiratory Distress

  MAUDE report 10900721 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANT PROCEDURE TO PLACE THE SPACER, BUT THE PROCEDURE WAS ABORTED DUE TO THE PATIENT BLEEDING OVER 200CC AFTER THE INCISION WAS MADE AND BEFORE DEVICE COULD BE PLACED. PHYSICIAN BELIEVES THE BLEEDING WAS CAUSED DUE TO THE PATIENT NOT HAVING STOPPED TAKING THEIR MEDICATION. PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: Blood Loss

  MAUDE report 10723398 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ABORTED PROCEDURE DUE TO AN UNKNOWN REASON. NO DEVICES WERE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10610799 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ABORTED PROCEDURE DUE TO AN UNKNOWN REASON. NO DEVICES WERE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10369732 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED WITHOUT IMPLANT DUE TO A FRACTURED SPINOUS PROCESS. THE SPINOUS PROCESS WAS NOT FRACTURED IN PREVIOUS X-RAYS BUT WAS LIKELY FRACTURED IN THE X-RAYS TAKEN ONCE SURGERY BEGAN. THE PATIENT RECEIVED A SPINE REFERRAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 10246310 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN IMPLANT PROCEDURE WAS ABORTED DUE TO THE PATIENT GOING INTO CARDIAC ARREST. WHILE THE PATIENT WAS UNDER ANESTHESIA THE INCISION HAD BEEN MADE AND THE DILATOR 1 AND CANNULA ASSEMBLY FROM THE SAME KIT WERE INSERTED. THE ANESTHESIOLOGIST SUGGESTED THAT THE PROCEDURE BE STOPPED BECAUSE THE PATIENT'S RHYTHMS WERE NOT CORRECT THEN THE PATIENT WENT INTO CARDIAC ARREST. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TAKEN TO THE ER. THE PATIENT IS NOW REPORTEDLY DOING WELL. THE PRODUCT WILL NOT BE RETURNED.

  Patient problems: Cardiac Arrest

  MAUDE report 9913203 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT WHILE ATTEMPTING TO IMPLANT THE SECONDED SPACER IN A 2 SPACER IMPLANT PROCEDURE, THE REP WITNESSED A SPINAL PROCESS FRACTURE AT L5. THE PHYSICIAN COMPLETED THE CASE AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9770602 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140004. One submission often covers many models, so check the product and lot details in each record.

• Z-1972-2023 · May 12, 2023 · Open, Classified
  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 Techn
• Z-0230-2023 · Oct 12, 2022 · Open, Classified
  Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm