STRATA® 42955Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169692718), received between Nov 23, 2016 and Feb 28, 2020 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH A HISTORY OF NORMAL PRESSURE HYDROCEPHALUS WITH PLACEMENT OF VENTRICULOPERITONEAL SHUNT. THE PATIENT CONTINUED TO SUFFER DIFFICULTY WITH HEADACHES AND BALANCE. THE VALVE THAT HAD BEEN PLACED HAD SUBSEQUENTLY BEEN RECALLED. BASED ON THE PATIENT'S FAILURE TO IMPROVE IN THE RECALL OF THE VALVE, THE SURGEON RECOMMENDED FOR INTERROGATION AND POSSIBLE REVISION OF THE VENTRICULOPERITONEAL SHUNT. AS A RESULT, THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. IT WAS STATED THE PATIENT WAS DOING WELL, AND THEIR HEADACHE WAS SLIGHTLY IMPROVED POST-OPERATIVELY.

  Patient problems: Ambulation or Postural Difficulties; Headache

  MAUDE report 9771662 ↗
• InjuryAug 23, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT HAD A HISTORY OF A PINEAL MASS TUMOR AS WELL AS ASSOCIATED HYDROCEPHALUS. THE PATIENT WAS IMPLANTED WITH A SHUNT SET AT 1.5 ON (B)(6) 2016. ON (B)(6) 2018, THE PATIENT WAS SEEN DUE TO OVER THE PAST SEVERAL MONTHS, THEY HAD A FEW EPISODES THAT THEY ATTRIBUTED TO SIGNIFICANT CONSTIPATION WHERE THEY WOULD PROGRESS TO DROWSINESS OVER THE COURSE OF 24-48 HOURS BUT THEN SUBSEQUENTLY IMPROVE THEREAFTER. THE PATIENT HAD A SIMILAR EPISODE THE MORNING OF (B)(6) 2018; HOWEVER, IN THE SETTING OF NO SIGNIFICANT IMPROVEMENT EVEN WITH AGGRESSIVE BOWEL MEDICATIONS OVER THE COURSE OF 48 HOURS AND DECREASED ORAL INTAKE ALONG WITH EPISODES OF EMESIS, THE PATIENT'S OPTED TO BRING THEM TO THE EMERGENCY ROOM FOR EVALUATION. UPON ARRIVAL, THE PATIENT WAS FOUND TO BE LETHARGIC. NONCONTRAST HEAD CT WAS PERFORMED THAT DEMONSTRATED EVIDENCE OF SLIGHT VENTRICULOMEGALY VERSUS PREVIOUS IMAGING . FURTHERMORE, A SHUNT SERIES WAS FOUND TO BE WITHIN NORMAL LIMITS. GIVEN THE PATIENT'S NEUROLOGIC EXAMINATION IN CONJUNCTION WITH CONCERNING RADIOGRAPHIC FINDINGS PLUS PREVIOUSLY NOTED CONCERN FOR RECALL, THE DOCTOR WOULD PROCEED WITH A SHUNT REVISION. THE VALVE WAS EXPLANTED AND REPLACED WITH

  Patient problems: Lethargy; Therapeutic Effects, Unexpected; Vomiting

  MAUDE report 8927978 ↗
• InjuryAug 5, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANT WITH THE DEVICE 2 1/2 YEARS AGO. IT WAS STATED THE DEVICE HAD ISSUES FROM THE START. MULTIPLE CT SCANS SHOWED THAT THE VENTRICLES WERE ALWAYS COLLAPSED BECAUSE WAY TOO MUCH FLUID WAS BEING DRAINED REGARDLESS OF HOW THE DEVICE WAS SET. THE PATIENT EXPERIENCED BRUTAL HEADACHES (WORST ICE CREAM FREEZE EVER ALL THE TIME AND ONLY MASSIVE AMOUNTS OF SLEEP WOULD HELP IT), BALANCE ISSUES (FELT LIKE THEY WERE ON A BOAT IN A STORM AND SEVERE ENOUGH WHERE THEY FELT UNSAFE TO DRIVE), FELL A LOT, SEVERE PAIN IN THE HEAD WHEN COUGHING AND SNEEZING (FELT LIKE THEY WERE HIT IN THE HEAD WITH A BASEBALL BAT, AND PAIN WOULD PERSIST, EXTREME CRIPPLING FATIGUE (WOULD SLEEP 10-12 HOURS EACH NIGHT AND ALWAYS SLEEP THROUGH AT LEAST ONE DAY ON THE WEEKEND), LIGHT SENSITIVITY (COULD NOT GO OUTSIDE WITHOUT SUNGLASSES, AND PAIN WHEN LOOKING AT COMPUTERS OR SCREENS), AND ISSUES WITH MOVIES (WOULD USUALLY END UP IN BED IN AGONY FOR 1-2 DAYS IF WE WENT TO THE THEATER). THE DEVICE ALSO DID NOT RESPOND CONSISTENTLY TO THE PROGRAMMER TO MEASURE OR CHANGE THE SETTINGS. THE DEVICE WAS REPLACED IN (B)(6) 2019, AND ALL OF THE SYMPTOMS WENT AWAY IMMEDIATELY FOLLOWING THE REPL

  Patient problems: Ambulation or Postural Difficulties; Extreme Exhaustion; Headache; Therapeutic Effects, Unexpected; Visual Disturbances

  MAUDE report 8861733 ↗
• InjuryMar 8, 2017Occlusion Within Device; Occlusion Within Device

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

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6390023 ↗
• InjuryFeb 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE FAILED AND WAS EXPLANTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6337526 ↗
• InjuryFeb 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

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

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6337524 ↗
• InjuryFeb 2, 2017Inaccurate Flow Rate; Appropriate Device Problem Term/Code Not Available; Inaccurate Flow Rate; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT BY NOVEMBER 29, 2016, THEIR SHUNT WAS APPEARING TO MALFUNCTION, AND A SHUNT TAP WAS ORDERED. THERE WAS SPONTANEOUS FLOW, NOT UNDER SIGNIFICANT PRESSURE. ASPIRATION OF 3 ML OF CLEAR CEREBROSPINAL FLUID WAS REMOVED. ON (B)(6), 2017, THE PATIENT WAS IN THE EMERGENCY ROOM WITH A HISTORY OF 12 HOURS OF HEADACHE AND RECURRENT VOMITING. ON EXAMINATION, THE PATIENT WAS NOTED TO BE AWAKE, ALERT, AND INTERACTIVE BUT VISIBLY UNCOMFORTABLE WITH A HEART RATE IN THE 50S. A CT SCAN REVEAL ENLARGEMENT OF THE BILATERAL VENTRICLUAR SYSTEM WITH UNCHANGED POSITIONING OF THE LEFT PARIETAL APPROACH VENTRICULAR CATHETER. ASPIRATION OF THEIR LEFT PARIETAL APPROACH VENTRICULOPERITONEAL SHUNT REVEALED CLEAR CEREBROSPINAL FLUID WITH SPONTANEOUS FLOW UNDER MODERATE PRESSURE, 10 ML OF WHICH WERE REMOVED. THE DOCTOR BELIEVED THERE WAS A SHUNT MALFUNCTION DUE TO THE PATIENT'S CLINICAL SIGNS AND SYMPTOMS INCLUDING HEADACHE, EMESIS, AND LETHARGY. ON (B)(6), 2017, THEIR SHUNT WAS REVISED. DURING THE PROCEDURE, THE DOCTOR DISCONNECTED THE VENTRICULAR CATHETER FROM THE VALVE AND FOUND THAT THE CATHETER DRAINED SPONTANEOUSLY CLEAR CEREBROSPINAL FLUID UNDER A SIGNIFICANT AM

  Patient problems: Headache; Lethargy; Therapeutic Response, Decreased; Vomiting

  MAUDE report 6299025 ↗
• InjuryJan 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE HAD MIGRATED AND PULLED THE VENTRICULAR CATHETER OUT OF THE VENTRICLE. ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A REVISION TO PLACE THE CATHETER BACK IN THE VENTRICLE. REPORTEDLY, THE THERE WAS NO INJURY TO THE PATIENT AND THEY WERE STABLE FOLLOWING THE REVISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6268108 ↗
• MalfunctionNov 30, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS FOUND TO BE FLIPPED. ACCORDING TO THE REPORT, THERE WAS SWELLING FROM THE IMPLANT PROCEDURE AROUND THE POCKET THAT WAS CREATED FOR THE DEVICE. IT WAS STATED THAT DUE TO THE SWELLING AND PATIENT SKIN, THE DEVICE FLIPPED. REPORTEDLY, THE SURGEON WAS ABLE TO MANUALLY MANEUVER THE DEVICE RIGHT SIDE UP THROUGH THE SKIN. THERE WAS NO INJURY TO THE PATIENT AND THE DEVICE WAS WORKING FINE AND ALWAYS DID. IT WAS REPORTED THAT THE SURGEON DID NOT FEEL THE DEVICE CAUSED THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6136939 ↗
• MalfunctionNov 23, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHEN ATTEMPTING TO ASPIRATE FLUID THROUGH THE DEVICE INTRAOPERATIVELY, IT WAS CLOGGED. ACCORDING TO THE REPORT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6126425 ↗

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