StrataRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 53 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 642
- Deaths reported
- 4
- Injuries reported
- 233
- Recalls
- 0
We found 53 models of Strata by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 642 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Sep 24, 2026 — classified as 4 deaths, 233 injuries, 405 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (185 reports).
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
Reports received per month, all models
Most reported Strata problems
Device problems
- Fluid/Blood Leak185
- Break112
- Fracture64
- Infusion or Flow Problem64
- Appropriate Device Problem Term/Code Not Available63
- Insufficient Device Problem Information54
- Mechanics Altered46
- Device Operates Differently Than Expected43
Patient problems
- No Clinical Signs, Symptoms or Conditions263
- No Known Impact Or Consequence To Patient201
- Therapeutic Response, Decreased38
- Insufficient Information31
- Headache26
- Unspecified Tissue Injury21
- Therapeutic Effects, Unexpected19
- Ambulation or Postural Difficulties14
Strata models
53 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Strata® 42866Shunt, central nervous system and components1 death160 reports
- Strata® 42866Shunt, central nervous system and components1 death75 reports
- Strata™ 42866Shunt, central nervous system and components56 reports
- Strata® 27819Shunt, central nervous system and components38 reports
- Strata™ 42856Shunt, central nervous system and components31 reports
- Strata® 42856Shunt, central nervous system and components30 reports
- Strata® 44420Shunt, central nervous system and components21 reports
- Strata® 42856Shunt, central nervous system and components20 reports
- STRATA® 42965Shunt, central nervous system and components14 reports
- Strata™ 44420Shunt, central nervous system and components14 reports
- Strata™ 92866Shunt, central nervous system and components14 reports
- Strata® 42365Shunt, central nervous system and components12 reports
- STRATA® 42955Shunt, central nervous system and components10 reports
- Strata® 44420Shunt, central nervous system and components10 reports
- Strata® 42365Shunt, central nervous system and components9 reports
- Strata® 27816Shunt, central nervous system and components1 death8 reports
- Strata® 44421Shunt, central nervous system and components8 reports
- Strata™ 46866Shunt, central nervous system and components8 reports
- Strata® 27816Shunt, central nervous system and components8 reports
- Strata™ 27819Shunt, central nervous system and components7 reports
- Strata™ 42365Shunt, central nervous system and components7 reports
- Strata® 44465Shunt, central nervous system and components6 reports
- Strata® 42355Shunt, central nervous system and components6 reports
- Strata® 44421Shunt, central nervous system and components6 reports
- Strata® 42836Shunt, central nervous system and components5 reports
- Strata® 42355Shunt, central nervous system and components5 reports
- Strata™ 27816Shunt, central nervous system and components4 reports
- Strata™ 42335Shunt, central nervous system and components4 reports
- Strata® 46866Shunt, central nervous system and components3 reports
- Strata™ 42355Shunt, central nervous system and components3 reports
- Strata™ 92866Shunt, central nervous system and components3 reports
- Strata® 27888Shunt, central nervous system and components3 reports
- Strata® 44410Shunt, central nervous system and components3 reports
- Strata® 27818Shunt, central nervous system and components3 reports
- Strata® 27815Shunt, central nervous system and components3 reports
- Strata® 42335Shunt, central nervous system and components2 reports
- Strata™ 42836Shunt, central nervous system and components2 reports
- Strata™ 42836Shunt, central nervous system and components2 reports
- Strata™ 44465Shunt, central nervous system and components2 reports
- Strata™ 46856Shunt, central nervous system and components2 reports
- Strata® 46866Shunt, central nervous system and components2 reports
- Strata™ 42836Shunt, central nervous system and components2 reports
- Strata® 27888Shunt, central nervous system and components1 report
- Strata® 27824Shunt, central nervous system and components1 report
- Strata® 46856Shunt, central nervous system and components1 report
- Strata® 44430Shunt, central nervous system and components1 death1 report
- Strata® 27740Shunt, central nervous system and components1 report
- Strata™ 46837Shunt, central nervous system and components1 report
- Strata™ 27740Shunt, central nervous system and components1 report
- Strata™ 27820Shunt, central nervous system and components1 report
- Strata™ 27822Shunt, central nervous system and components1 report
- Strata® 27817Shunt, central nervous system and components1 report
- Strata® 46856Shunt, central nervous system and components1 report
Recent Strata adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Infusion or Flow Problem
Medtronic received information regarding an adjustable shunt. It was reported that after implantation of the flow-diverting device, testing revealed that it was not patent. After an intraoperative replacement with a new product, it became patent. There was a procedure delay of 30 minutes. The patient's status at the time of the report was alive- no injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882381 ↗MalfunctionSep 11, 2026Mechanics Altered
Medtronic received information regarding an adjustable valve. It was reported that the patient was diagnosed with idiopathic intracranial hypertension after failure of conservative management. Following a detailed discussion of the available treatment options with the patient and their family, the decision was made to proceed with placement of a lumboperitoneal (LP) shunt. Prior to surgery, the valve was programmed to a setting of 1.5.The procedure was performed on (b)(6) 2025, and was uneventful. Following surgery, the patient experienced gradual and significant improvement in her symptoms. Approximately one month postoperatively, however, the patient reported recurrence of her symptoms, including headaches, nausea and blurred vision. Appropriate investigations were performed to assess the position of the shunt, which demonstrated that the shunt was appropriately positioned without evidence of malposition. The valve setting was subsequently checked and was found to have changed from the original setting of 1.5 to 1.0. The valve was reprogrammed to 1.5, following which the patient's symptoms again improved. Of note, during this period, the patient had not undergone MRI examination
Patient problems: Blurred Vision; Headache; Nausea
MAUDE report 50732520 ↗InjurySep 10, 2026Break; Fracture; Infusion or Flow Problem
Medtronic received information regarding an adjustable valve. It was reported the patient underwent ventriculoperitoneal shunt surgery on (b)(6) 2026. The shunt valve was intact intraoperatively, with no abnormalities. On (b)(6) 2026, after the patient¿s condition improved, the patient was transferred to rehabilitation. Physical examination revealed subcutaneous fluid accumulation and poor cerebrospinal fluid drainage. On (b)(6) 2026, ventriculoperitoneal shunt adjustment surgery was performed; the shunt valve was found broken intraoperatively and was replaced.
Patient problems: Insufficient Information
MAUDE report 50716935 ↗MalfunctionAug 27, 2026Mechanical Jam
Medtronic received information regarding an adjustable valve. It was reported that further tests were conducted with the programmer, including the use of different equipment confirming that the programmer was functioning correctly. However, the valve was not responding to attempts to change its settings; it remained at the 1.0 setting, even after attempts to switch to other parameters and subsequently return to 0.5. Additional programming attempts were made including applying greater pressure over the valve site but resulted in no change in performance. Potential magnetic field interference was also investigated, but no such issue was identified. A CT scan showed the valve was well-positioned. Furthermore, according to the information received, the device functioned properly for approximately one year following implantation. Thus, the current issue appeared to be specific to the valve's adjustment mechanism, which was failing to respond to programming attempts. The physician raised the possibility of obtaining a replacement valve alone, without needing to replace the ventricular and peritoneal catheters. At present, provided the patient remains clinically stable, the family was som
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484018 ↗InjuryJul 30, 2026Mechanics Altered; Insufficient Device Problem Information
Medtronic received information regarding an adjustable shunt. It was reported that the shunt was implanted on January 30, 2024. The shunt failed to function for hydrocephalus spinal fluid drainage and was successfully replaced on (b)(6), 2025.
Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Headache; Incontinence; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 50083054 ↗MalfunctionJul 6, 2026Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THERE WAS LIQUID LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716083 ↗MalfunctionJun 11, 2026Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT AFTER THE PRODUCT WAS OPENED, FLUID LEAKED FROM THE ABDOMINAL/PERITONEAL END. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473021 ↗MalfunctionMay 29, 2026Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE IMPLANTATION PROCEDURE WAS SCHEDULED FOR APRIL 17, 2026. AFTER OPENING THE PACKAGE, LIQUID LEAKAGE FROM THE PRODUCT WAS NOTICED. THERE WAS A PROCEDURE DELAY OF 3 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACK UP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330368 ↗MalfunctionMay 27, 2026Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THERE WAS NO FUNCTION. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299608 ↗MalfunctionMay 20, 2026Break; Fluid/Blood Leak; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE RESERVOIR AT THE FRONT END OF THE VALVE WAS DAMAGED AND LEAKING FLUID. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230384 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A VENTRICULOPERITONEAL SHUNT PROCEDURE DUE TO POST-TRAUMATIC HYDROCEPHALUS. POSTOPERATIVELY, THE PATIENT DEVELOPED A SEVERE INFECTION AND THE IMPLANTED DEVICES WERE SUBSEQUENTLY REMOVED. AFTER ALL CLINICAL INDICATORS MET THE REQUIRED STANDARDS, A REPEAT VENTRICULOPERITONEAL SHUNT PROCEDURE WAS PERFORMED USING NEW DEVICES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: Unspecified Infection
MAUDE report 25229868 ↗InjuryMay 14, 2026Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE MANUAL AND ELECTRONIC PROGRAMMERS SHOWED THE VALVE TO BE AT A DIFFERENT PRESSURE LEVEL SETTING THAN WHEN CONFIRMING THE PRESSURE LEVEL SETTING WITH X-RAY. THE X-RAYS WERE TAKEN IMMEDIATELY AFTER PROGRAMMING THE PATIENT. IT WAS NOTED THAT THE SURGEON WAS VERY EXPERIENCED WITH THE VALVE AND TRIED PROGRAMMING/CHECKING WITH BOTH THE MANUAL AND ELECTRONIC PROGRAMMERS. THE VALVE WAS EXPLANTED AND REPLACED WITH AN NON-ADJUSTABLE VALVE. THE ORIGINAL SURGERY WAS (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174436 ↗MalfunctionMay 14, 2026Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON (B)(6) 2026, DURING A VENTRICULOPERITONEAL SHUNT PROCEDURE, A PATENCY TEST WAS PERFORMED PRIOR TO IMPLANTATION. IT WAS FOUND THAT THE OTHER END HAD POOR PATENCY. AFTER REPEATED TESTING, IT REMAINED NON-PATENT. THE DEVICE WAS REPLACED. THERE WAS A PROCEDURE DELAY OF 10 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173371 ↗MalfunctionApr 30, 2026Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT WHEN THE IMPLANTATION PROCEDURE WAS NEAR COMPLETION, THE PHYSICIAN IDENTIFIED A FRACTURE OF THE ANTI-SIPHON CHAMBER. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW PRODUCT. THERE WAS A PROCEDURE DELAY OF 20 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS HYPERTENSION AND HYDROCEPHALUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25043755 ↗InjuryApr 9, 2026Mechanical Jam
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE LUMBOPERITONEAL VALVE WAS IMPLANTED ON (B)(6) 2024, AND AFTER ALMOST 2 YEARS, THE DEVICE SEEMED TO HAVE A MALFUNCTION AS THE HEALTHCARE PROFESSIONAL COULD NOT CHANGE THE PROGRAM LEVEL. 3 DIFFERENT PROGRAMMERS WERE TRIED AND CHECK WITH X-RAYS. THE DEVICE WAS TO BE REPLACED IN THE NEXT WEEKS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831218 ↗
Other Medtronic Ps Medical, Inc. products
All Medtronic Ps Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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