Strata® 42856 (UDI 00613994804631)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00613994804631), received between Mar 24, 2017 and Jan 13, 2026 — classified as 10 injuries, 10 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K060681); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT LATERAL VENTRICLE-ABDOMINAL CAVITY SHUNT IMPLANTATION FOR HYDROCEPHALUS UNDER GENERAL ANESTHESIA, WITH A BRAIN-THORACOABDOMINAL SHUNT SYSTEM AND COMPONENTS. THE IMPLANTATION PROCEDURE WAS SMOOTH, THE PROCESS FOLLOWED STANDARD PROTOCOLS, AND NO ADVERSE REACTIONS OCCURRED. THE PATIENT WAS FOLLOWED UP FOR SIX YEARS UNTIL THE END OF 2017, WHEN RECURRENT HEADACHES DEVELOPED AND PROGRESSIVELY WORSENED. IN (B)(6) 2018, THE SYMPTOMS ESCALATED TO SEVERE HEADACHE, VOMITING, AND CONVULSIONS, LEADING TO READMISSION. THE PRESSURE SETTING OF THE HYDROCEPHALUS SHUNT DEVICE WAS ADJUSTED. ON (B)(6) 2018, THE PATIENT DECIDED TO TRANSFER TO ANOTHER HOSPITAL, WHERE DOCTOR IN (B)(6) DISCOVERED DRAINAGE TUBE MALFUNCTION AND REPLACED THE DRAINAGE TUBE. THIS RESULTED IN OPTIC NERVE ATROPHY AND COMPLETE LOSS OF VISION, AND THE PATIENT WAS DIAGNOSED WITH FIRST-DEGREE VISUAL IMPAIRMENT. IT WAS NOTED THAT THE SURGERY TOOK PLACE MORE THAN 15 YEARS AGO, AND THE PATIENT HAD NOT VISITED THE HOSPITAL SINCE. SINCE THE SPECIFIC REPLACEMENT SURGERY WAS PERFORMED AT ANOTHER HOSPITAL, THE EXACT PRODU

  Patient problems: Convulsion/Seizure; Headache; Loss of Vision; Nerve Damage; Optical Nerve Damage; Vomiting

  MAUDE report 24055705 ↗
• InjuryJul 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE/SHUNT. IT WAS REPORTED THAT THE PATIENT WAS REQUESTING THEIR DEVICE BE EXPLANTED FOR SYMPTOMS INCLUDING PAIN AND TENDERNESS OVER THE VALVE AND "POSITIONAL HEADACHES" WITH A SENSATION OF EYE TUGGING AND TINNITUS. THEY HAVE INCREASED THE PATIENTS SETTINGS TO SEE IF IT HELPED WITH SYMPTOMS, BUT HAD NOT HAD RELIEF. IT WAS CURRENTLY SET AT 2.5. THIS EVENT HAS BEEN ONGOING OVER THE PAST YEAR. THE PATIENT STATUS IS CURRENTLY UNCHANGED AND IS WAITING FOR SURGERY THAT WILL TAKE PLACE ON (B)(6) 2024. THE CALVE WAS IMPLANTED ON (B)(6) 2017.

  Patient problems: Discomfort; Headache; Pain; Tinnitus

  MAUDE report 19822316 ↗
• MalfunctionJan 8, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF LOW CEREBROSPINAL FLUID (CSF) AS THE DAY PROGRESSED. THE ORIENTATION OF THE IMPLANT WAS THAT THE CATHETER EXITED THE TEMPORAL LOBE CAVITY, THE CATHETER LOOPED UP AROUND A BONE SCREW, THE INLET OF THE VALVE POINTED DOWN, THE OUTLET OF THE VALVE POINTED UP, AND THE CATHETER LOOPED DOWN AT THE OUTLET PRIOR TO BEING TUNNELED DOWN THE CRANIUM AND NECK. IT WOULD SEEM THAT THE SIPHON CONTROLMEASURE OF THE DELTA CHAMBER WOULD REMAIN OPEN WHEN THE PATIENT WAS UPRIGHT WITH THE VALVE IN THIS ORIENTATION (VALVE IMPLANTED UPSIDE DOWN).

  Patient problems: Insufficient Information; Pain

  MAUDE report 18465434 ↗
• InjuryApr 1, 2022Complete Blockage; Adverse Event Without Identified Device or Use Problem; Complete Blockage; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. THE PATIENT SYMPTOMS WERE CONSIST WITH THE PAST SHUNT MALFUNCTIONS. NO RUNOFF THROUGH VALVE WERE SEEN WHEN TESTED INTRAOPERATIVELY. THE VENTRICULAR CATHETER WAS ALSO OCCLUDED, BOTH ARE GOING TO BE REPLACED WITH DIFFERENT PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS WERE UNKNOWN. IT WAS ALSO UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS CONFIRMED THAT THE CATHETER WAS OCCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978565 ↗
• InjuryMar 23, 2022Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT DURING THE LATEST VISITS, THE DOCTOR NOTICED THAT THE SHUNT PRESSURE HAD BEEN CHANGED COMPARING TO THE LAST CHECK (EX: INSTEAD OF 1.5 IT WAS 2.5). THE PATIENT DID NOT HAVE AN MRI SCAN. THE SHUNT HAS BEEN IMPLANTED SINCE (B)(6) 2017. THE PATIENT IS IN DANGER OF LOSING SIGHT. THIS WAS REPORTED OUTSIDE OF A PROCEDURE.

  Patient problems: Loss of Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861851 ↗
• MalfunctionJul 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12192907 ↗
• MalfunctionApr 8, 2019Break; Fracture; Mechanics Altered; Break; Fracture; Mechanics Altered

  INFORMATION WAS RECEIVED REGARDING A PATIENT IMPLANTED WITH A STRATA VALVE. IT WAS REPORTED THAT THE PATIENT'S SON KICKED HIM IN THE HEAD AT THE SITE OF THE IMPLANT, AND THAT THE VALVE KEEPS SWITCHING SETTINGS. THE HEALTHCARE PROFESSIONAL (HCP) HAS ADJUSTED THE VALVE THREE TIMES AND BELIEVES THE DEVICE WAS DAMAGED BY IMPACT AND WOULD LIKE TO REPLACE, BUT THE PATIENT HAS NOT YET CONSENTED. THE PATIENT NOTED THEY HAVEN'T BEEN IN CLOSE PROXIMITY TO STRONG MAGNETS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8492076 ↗
• InjuryMay 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE VALVE WAS NEVER FULLY IMPLANTED. THE LEAKING OCCURRED INTRA-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522571 ↗
• MalfunctionApr 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN FOUND THAT THE VALVE WAS LEAKING. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451558 ↗
• InjuryMar 30, 2018Device Operates Differently Than Expected; Mechanics Altered; Device Operates Differently Than Expected; Mechanics Altered

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS NOT FUNCTIONING PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385806 ↗
• MalfunctionMar 13, 2018Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT IT TOOK SEVERAL ATTEMPTS BEFORE THE VALVE WOULD PROGRAM PROPERLY. AFTER ATTACHING THE VALVE TO THE PATIENT'S VENTRICULAR CATHETER, THE VALVE WOULD NOT ALLOW CEREBROSPINAL FLUID (CSF) TO PASS THROUGH. THERE WERE NO PATIENT SYMPTOMS OR HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336141 ↗
• MalfunctionFeb 6, 2018Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available; Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE VALVE HAD BEEN SET TO 1.5, BUT NO FLUID FLOWED DISTALLY. THE CAUSE WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7244194 ↗
• InjuryJan 17, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED A SUBDURAL ON (B)(6) 2017. THE PATIENT UNDERWENT A LEFT FRONTAL CRANIOTOMY FOR EVACUATION OF THE ACUTE SUBDURAL, THOUGH THE DATE WAS NOT PROVIDED. THE CAUSE OF THE SUBDURAL WAS UNKNOWN. THE SUBDURAL WAS NOT RESOLVED, BUT HAD SIGNIFICANTLY DECREASED.

  Patient problems: Hemorrhage, Subdural

  MAUDE report 7201686 ↗
• MalfunctionNov 6, 2017Break; Break

  IT WAS REPORTED THAT WHILE IMPLANTING THE VALVE, ONE OF THE PORTS BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7004206 ↗
• MalfunctionSep 25, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A MAGNETIC RESONANCE IMAGING (MRI) WAS ORDERED BY GENETICS FOR THE PATIENT, AND THE PROGRAMMABLE VALVE WAS INDICATED ON THE ORDER. IT WAS STATED THE PATIENT HAD MRA/V OF THE CHEST, ABDOMEN, AND PELVIS. NEUROSURGERY WAS NOT CONTACTED REGARDING THE PATIENT HAVING THE MRI, AND THERE WAS NO REQUEST FOR INTERROGATION OF THE SHUNT VALVE AFTER THE MRI. THE PATIENT WENT HOME AND BEGAN HAVING PROGRESSIVELY WORSENING HEADACHE, EMESIS, DIAPHORESIS, AND MALAISE. THE MOTHER OF THE PATIENT CONTACTED THE NEUROSURGERY OFFICE THE FOLLOWING MORNING AND BROUGHT THE PATIENT IMMEDIATELY TO THE CLINIC. THE SHUNT VALVE WAS FOUND AT 0.5 AND SHOULD HAVE BEEN AT 2.5. THE PATIENT WAS REPROGRAMMED TO 2.5. IT WAS NOTED THE PATIENT WAS MONITORED IN THE CLINIC AND OBTAINED A HEAD CT WHICH WAS STABLE. THE SYMPTOMS WERE RESOLVED BEFORE THE EXIT FROM THE CLINIC AND NEURO INTACT.

  Patient problems: Headache; Malaise; Sweating; Vomiting

  MAUDE report 6892025 ↗
• MalfunctionAug 10, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A HOLE WAS DISCOVERED IN THE DEVICE. ACCORDING TO THE REPORT, THE DOCTOR OPENED A 2ND DEVICE WITH A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. IT WAS STATED THAT THE DOCTOR CHECKED THE DEVICE BEFORE THE PROCEDURE STARTED SO DELAY WAS NEGLIGIBLE AS THEY PULLED ANOTHER VALVE FROM THE SHELF IN THE NEXT ROOM. REPORTEDLY, THERE WAS NO OTHER IMPACT, AND THE DEVICE HAD NO CONTACT WITH THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6785359 ↗
• InjuryJun 21, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DISTAL PART OF THE VALVE WAS NOT DRAINING. ACCORDING TO THE REPORT, A REVISION OF THE SHUNT HAD TO BE DONE TO REPLACE IT WITH ANOTHER VALVE. REPORTEDLY, THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6658125 ↗
• InjuryMay 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD A 3 TESLA MR SCAN ON (B)(6) 2017. ACCORDING TO THE REPORT, FOLLOWING THE SCAN, THE PATIENT WORSENED AND ¿THEY SUSPECTED FROM THE ADJUSTED LEVEL¿ OF THE VALVE. THE PERFORMANCE LEVEL WAS ADJUSTED, BUT NOTHING HAD BEEN CHANGED IN THE PATIENT'S STATUS. AS A RESULT OF THIS, THE CLINIC BELIEVED THAT THE ADJUSTMENT MECHANISM OF THE VALVE WAS NOT WORKING PROPERLY AND WAS BROKEN. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW ONE. REPORTEDLY, THE PATIENT'S STATUS WAS OKAY AND FINE AFTER THE REVISION AND WOULD BE LEAVING THE HOSPITAL ON (B)(6) 2017.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6571296 ↗
• InjuryApr 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT'S DEVICE WAS CHECKED AFTER AN MRI AND HAD THE SETTING OF 2.5 ON (B)(6) 2016, AND ON A FOLLOW UP APPOINTMENT ON (B)(6) 2017, THE SETTING WAS ON 0.5. ACCORDING TO THE REPORT, THE PATIENT WAS NOT AROUND ANY MAGNETS NOR USED ELECTRONIC DEVICES. IT WAS STATED THE PATIENT WAS KEPT AWAY FROM MAGNETS. REPORTEDLY, THE PATIENT¿S MOTHER WAS WORRIED WITH THE DEVICE CHANGING FROM THE LOWEST SETTING TO THE HIGHEST SETTING, IT COULD CAUSE ANOTHER BLEED IN THE PATIENT¿S BRAIN. IT WAS NOTED THAT THE PATIENT HAS HAD SEVERAL MRI'S WHILE HAVING THEIR DEVICE. THE NEUROSURGEON ADJUSTED IT BACK TO 2.5 AND SAID THEY WOULD SEE THE PATIENT IN 6 MONTHS FOR A CHECKUP, HOWEVER, IT WAS INDICATED THE PATIENT HAD A FOLLOW UP APPOINTMENT WITH THE NEUROSURGEON TO CHECK THE SETTINGS ON (B)(6) 2017. IT WAS MENTIONED THAT THE PATIENT HAD DEVELOPMENT ISSUES SO THEY DIDN'T INDICATE SYMPTOMS TO KNOW WHEN THE VALVE HAD CHANGED SETTINGS.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 6472171 ↗
• MalfunctionMar 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WERE ISSUES EXPERIENCED WHEN THEY INITIALLY TRYING TO ADJUST THE PERFORMANCE LEVEL PRIOR TO IMPLANT. ACCORDING TO THE REPORT, THE PHYSICIAN DECIDED TO USE ANOTHER PRODUCT TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6434374 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060681. One submission often covers many models, so check the product and lot details in each record.

• Z-1116-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHU
• Z-1121-2017 · Jan 17, 2017 · Terminated
  Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata