iVASRecalls & reported problems across all models

We found 10 models of iVAS by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Aug 24, 2026 — classified as 1 death, 16 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Fracture” (42 reports).

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

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

iVAS 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. Nov 9, 2017Class IITerminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1254-2018 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗

2. Nov 9, 2017Class IITerminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1253-2018 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported iVAS problems

iVAS models

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

• iVAS 0705315000

  CEMENT, BONE, VERTEBROPLASTY
  1 recall3 reports
• iVAS 0705310000

  CEMENT, BONE, VERTEBROPLASTY
  1 recall1 report
• iVAS 0705115000

  CEMENT, BONE, VERTEBROPLASTY
  1 recall0 reports
• iVAS 0306330000

  Injector, vertebroplasty (does not contain cement)
  41 reports
• iVAS 0306530000

  Injector, vertebroplasty (does not contain cement)
  3 reports
• iVAS 0306116000

  INSTRUMENT, BIOPSY
  2 reports
• iVAS 808110000

  CEMENT, BONE, VERTEBROPLASTY
  2 reports
• iVAS 808115000

  CEMENT, BONE, VERTEBROPLASTY
  2 reports
• iVAS 808115800

  CEMENT, BONE, VERTEBROPLASTY
  2 reports
• IVAS 1021315000

  CEMENT, BONE, VERTEBROPLASTY
  1 death1 report

Recent iVAS adverse event reports

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

• InjuryAug 24, 2026Fracture

  It was reported that the cannula broke inside the the patient, the case was stopped and the canula was removed the following day.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50411877 ↗
• MalfunctionMay 12, 2026Fracture

  IT WAS REPORTED THAT A PIECE OF THE CANNULA WAS LEFT IN THE PEDICLE OF THE PATIENT, WHICH WAS CONFIRMED VIA X-RAY. THE PROCEDURE WAS INTENDED TO COMPLETE BOTH SIDES; HOWEVER, THE SECOND SIDE WASN'T COMPLETED. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25148059 ↗
• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24953814 ↗
• InjuryFeb 27, 2026Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471814 ↗
• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24163959 ↗
• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD CODE NOT FOUND.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163103 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23368320 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22647336 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 6 EVENTS FOR THE FAILURE: FRACTURE. 6 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22647061 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21878601 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. TWO EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21201191 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201032 ↗
• InjuryOct 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PLASTIC HANDLED BROKE OFF DURING THE PROCEDURE. PATIENT WAS TRANSPORTED TO ANOTHER FACILITY TO GET A HAMMER TO REMOVE THE BROKEN OFF PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551802 ↗
• MalfunctionOct 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DURING THE PROCEDURE, THE ACCESS CANNULA BROKE WHEN IT WAS BEING REMOVED. PER A CT SCAN, IT BROKE OFF FLUSH WITH THE VERTEBRAL PEDICLE. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS A 20 MINUTE DELAY REPORTED AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20408301 ↗
• InjurySep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE 11G ACCESS CANNULA BENT AND CONSEQUENTLY BROKE WHILE BEING REMOVED FROM VERTEBRAL BODY. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT IMPACT, OR MEDICAL INTERVENTION. THERE WAS A SURGICAL DELAY OF 2 HOURS TO REMOVE THE BROKEN DEVICE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136898 ↗

Other Stryker Corporation products

• RemB7 models · 3,073 reports
• Prime Series21 models · 1,548 reports · 2 recalls
• TARGET114 models · 1,077 reports
• ProCuity17 models · 368 reports · 13 recalls
• Spetzler-Malis20 models · 7 reports · 19 recalls
• SYNCHRO 28 models · 313 reports · 9 recalls
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls