STRATA® 42965Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169692701), received between Nov 23, 2016 and Jun 10, 2022 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K152700); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2022Infusion or Flow Problem; Mechanics Altered; Insufficient Device Problem Information; Infusion or Flow Problem; Mechanics Altered; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN MR SHUNT. IT WAS REPORTED THAT THE PATIENT HAD THE SHUNT IMPLANTED IN 2016. TWO MONTHS LATER, THE MR RECALL LETTER WENT OUT. THE SHUNT WAS ADJUSTED FROM 2.0 TO .5 WITHIN 6 MONTHS. IN 2020, THE PATIENT HAD A CT OF THEIR SINUSES WHEREBY THE ENT SAW A POCKET OF FLUID AND SENT THE PATIENT TO A NEUROSURGEON. THE NEUROSURGEON DETERMINED THAT THE SHUNT WAS OVERDRAINING, AND SET THE VALVE TO 1.5. TWO YEARS LATER, THE PATIENT STARTED HAVING HEADACHES AND BLURRY VISION "AGAIN." THE NEWEST CT SCANS SHOWED THEIR VENTRICLES "CONSIDERABLY LARGER" THAN THEY WERE IN THE 2020 SCANS. THE PATIENT STAYED OVERNIGHT IN THE ER. THEY FIRST ADJUSTED THE SHUNT DOWN TO .5 AGAIN. IN THE MORNING, THEY SET IT TO 1.0. A MONTH LATER, THE SHUNT SETTING WAS FLUCTUATING BETWEEN 1.0 AND 1.5. THE DOCTOR DID AN EXPLORATORY SURGERY AND DETERMINED THAT THE SHUNT WAS COMPLETELY NON-FUNCTIONAL. IT WAS REPLACED WITH A DIFFERENT VALVE IN A LATER SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Cerebral Ventriculomegaly; Headache

  MAUDE report 14653926 ↗
• InjuryMay 24, 2022Nonstandard Device; Therapeutic or Diagnostic Output Failure

  I HAD THE STRATA MR VP SHUNT IMPLANTED ON (B)(6) 2016. TWO MONTHS LATER, THE MR RECALL LETTER WENT OUT - THE MR WAS ADJUSTED FROM 2.0 TO 0.5 WITHIN 6 MONTHS. IN 2020, I HAD A CT OF MY SINUSES WHEREBY THE ENT SAW A POCKET OF FLUID AND SENT ME TO (B)(6) NEUROSURGEON (B)(6). DR. (B)(6) DETERMINED THE SHUNT WAS OVERDRAINING, AND SET THE VALVE TO 1.5. FAST-FORWARD TWO YEARS, AND I STARTED HAVING HEADACHES AND BLURRY VISION AGAIN. NEWEST CT SCANS SHOWED MY VENTRICLES CONSIDERABLY LARGER THAN THEY WERE IN THE 2020 SCANS. I STAYED OVERNIGHT IN THE ER AT (B)(6) ON (B)(6) THEY FIRST ADJUSTED MY SHUNT DOWN TO 0.5 AGAIN, THEN IN THE MORNING, SET IT TO 1.0. A MONTH LATER, THE SHUNT SETTING WAS FLUCTUATING BETWEEN 1.0 AND 1.5. DR. (B)(6) DID AN EXPLORATORY SURGERY AND DETERMINED THE STRATA MR TO BE COMPLETELY NON-FUNCTIONAL. ON MONDAY, (B)(6), HE REPLACED THE STRATA MR WITH A STRATA II VALVE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Blurred Vision; Headache

  MAUDE report 14494916 ↗
• InjuryAug 23, 2019Mechanical Jam; Mechanics Altered; Mechanical Jam; Mechanics Altered

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT SINCE THEIR SHUNT REPLACEMENT, THE PATIENT HAD NO ONGOING CONCERNS WITH THEIR SHUNT OR SIGNIFICANT HYDROCEPHALUS SYMPTOMS.

  Patient problems: Ambulation or Postural Difficulties; Dizziness; Dysphasia; Fall; Headache; Nausea; Numbness

  MAUDE report 8926295 ↗
• InjuryJun 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS CURRENTLY AN INPATIENT AT THEIR FACILITY. IT WAS NOTED THEY HAD ATTEMPTED TO ADJUST THE DEVICE IN THE OFFICE. AFTER EXPLANT, THE DEVICE WAS SENT TO PATHOLOGY. IN THEIR RECORDS, THE PATIENT HAS HAD AT LEAST 2 MAGNETIC RESONANCE IMAGING (MRI) DONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598130 ↗
• InjuryFeb 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL 4 TIMES SINCE SHE WAS IMPLANTED WITH A SHUNT ON (B)(6) 2016. THE REASON FOR THE HOSPITALIZATION WAS NOTED AS SHUNT FAILURE. THE PATIENT EXPERIENCED NAUSEA, VOMITING, HEADACHES, BLURRED VISION, DOUBLE VISION, UNSTEADY GAIT, AND EXTREME FATIGUE RELATED TO THE PREVIOUSLY NOTED SHUNT FAILURE. THE PATIENT HAD HER VALVE ADJUSTED TO A SETTING OF 2.5, BUT REPORTED THAT SHE DOES NOT FEEL ANY BETTER THAN WHEN IT WAS AT A LOWER SETTING. THE PATIENT HAS AN APPOINTMENT WITH HER HEALTH CARE PROVIDER (HCP) ON (B)(6) 2018 TO POTENTIALLY READJUST THE VALVE TO ANOTHER SETTING. THE PATIENT'S MEDICAL HISTORY INCLUDES A BRAIN TUMOR ON HER BRAIN STEM, WHICH IS THE REASON FOR THE SHUNT IMPLANTATION.

  Patient problems: Ambulation or Postural Difficulties; Blurred Vision; Extreme Exhaustion; Headache; Nausea; Visual Impairment; Vomiting

  MAUDE report 7276503 ↗
• MalfunctionOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD TO BE EXTERNALIZED FOR A PSEUDOCYST SO THE PHYSICIAN CHANGED OUT THEIR VALVE WHEN THEY PUT THE NEW SHUNT IN. THE VALVE WAS REMOVED NOT BECAUSE IT FAILED BUT PROACTIVELY AS PART OF THE OVERALL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6936790 ↗
• InjuryAug 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS EXPLANTED DUE TO DEVICE FAILURE OR MALFUNCTION. ACCORDING TO THE REPORT, THE PHYSICIAN ALLEGED A DEFICIENCY IN THE DEVICE PERFORMANCE.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6817784 ↗
• MalfunctionJun 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT PRESENTED FOR AN OFFICE VISIT ON (B)(6) 2017. ACCORDING TO THE REPORT, THE PATIENT EXPERIENCED NO IMPROVEMENT TO THEIR BASELINE CONDITION SINCE THE LAST ADJUSTMENT THAT WENT FROM A SETTING OF 2.0 TO 1.5. IT WAS STATED THAT THE DEVICE WAS ADJUSTED FROM 1.5 TO 1.0 WITHOUT DIFFICULTY. THE PATIENT THEN EXPERIENCED A WORSENING OF NAUSEA AND VOMITING AND WENT TO THE EMERGENCY ROOM ON (B)(6). REPORTEDLY, THE DEVICE WAS ADJUSTED TO 1.5, BUT DIFFICULTY WAS EXPERIENCED WHEN ADJUSTING. THE PATIENT HAD AN X-RAY THAT SHOWED THE DEVICE BEING AT 1.0. IT WAS REPORTED THAT THE PATIENT DECLINED TO HAVE THE DEVICE READJUSTED TO 1.5 BECAUSE THEIR SYMPTOMS RESOLVED THE NEXT DAY. THE DEVICE WAS NOT EXPLANTED AND THE PATIENT WAS AT HOME.

  Patient problems: Nausea; Vomiting

  MAUDE report 6620903 ↗
• InjuryJun 7, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT PRESENTED WITH WORSENING HYDROCEPHALUS SYMPTOMS, INDICATING THE VENTRICULAR PERITONEAL SHUNT WAS NOT FUNCTIONING CORRECTLY. ACCORDING TO THE REPORT, THE PATIENT WAS EXPERIENCING VARIABLE CONSCIOUS STATES ELEVATING THEIR RISK OF ASPIRATION. THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT BY REDUCING THE PERFORMANCE LEVEL TO 0.5. REPORTEDLY, THE STATUS OF THE PATIENT DID NOT CHANGE AND THE PHYSICIAN ELECTED TO TAKE THE PATIENT BACK TO THEATRE AND REVISE THE SHUNT. THE PRODUCT WAS REPLACED AND IT WAS STATED THE PHYSICIAN BELIEVED THE CAUSE WAS INTERMITTENT SHUNT BLOCKAGE, THOUGH NO SPECIFIC COMPONENT WAS IDENTIFIED. IT WAS ADDED THAT THE VALVE WAS BATHED IN THE STANDARD RINGER¿S SOLUTION PRIOR TO IMPLANT AND THERE WERE NO MRI¿S PERFORMED WHILE THE SHUNT WAS IMPLANTED.

  Patient problems: Hydrocephalus; Therapeutic Response, Decreased

  MAUDE report 6620198 ↗
• InjuryJun 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS EXPERIENCING HEADACHES AND LETHARGY. ACCORDING TO THE REPORT, THERE WERE NO ADJUSTMENTS DONE AFTER IMPLANT. THE PATIENT UNDERWENT SHUNT REPLACEMENT ON (B)(6) 2017. REPORTEDLY, THE PATIENT WAS STABLE. IT WAS NOTED THAT PRIOR TO IMPLANT, THE VALVE WAS IRRIGATED WITH A SOLUTION OF BACITRACIN AND NORMAL SALINE.

  Patient problems: Headache; Lethargy; Therapeutic Response, Decreased

  MAUDE report 6606364 ↗
• InjuryMar 17, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS NOT ALLOWING CEREBROSPINAL FLUID (CSF) TO DRAIN. ACCORDING TO THE REPORT, THE SURGEON DECIDED TO REVISE THE SHUNT SYSTEM AND TEST ALL COMPONENTS. IT WAS STATED THAT CSF FLOWED FROM THE VENTRICULAR CATHETER. THE SURGEON THEN CONNECTED PRIMED MANOMETER TUBING TO THE PROXIMAL END OF THE VALVE AND RAISED THE TUBING TO A SUFFICIENT HEIGHT. NO FLOW OF FLUID THROUGH THE TUBING WAS NOTED. IT WAS THEN INDICATED THAT THE SURGEON DISCONNECTED THE VALVE FROM THE PERITONEAL CATHETER AND CONNECTED THE MANOMETER TUBING TO THE CATHETER. FLUID FLOWED THROUGH THE TUBING. THE SURGEON CONCLUDED THAT VALVE WAS BLOCKED AND REPLACED THE VALVE.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6414924 ↗
• InjuryMar 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE FAILED AND WAS EXPLANTED. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6411567 ↗
• MalfunctionDec 22, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THE VALVE WAS BATHED IN ANTIBIOTIC SOLUTION, BACITRACIN PRIOR TO IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6199862 ↗
• MalfunctionNov 23, 2016Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS RIPPED INTRAOPERATIVELY. ACCORDING TO THE REPORT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6126428 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152700. One submission often covers many models, so check the product and lot details in each record.

• Z-1702-2017 · Feb 22, 2017 · Terminated
  The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the