Strata® 44465Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169466210), received between Feb 2, 2017 and Dec 20, 2019 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K123524); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2019Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE SHUNT WAS IMPLANTED ON (B)(6), 2019 AND SET AT A PERFORMANCE LEVEL OF 2. THE PATIENT RETURNED DISPLAYING LOW PRESSURE SYMPTOMS, AND THE VALVE WAS AT 0.5 WITH NO MRI OR KNOWN MAGNETIC INFLUENCES. THE VALVE WAS RESET TO A PERFORMANCE LEVEL OF 1.5 BUT WAS LATER CHECKED AND AGAIN FOUND TO BE AT 0.5. A REVISION SURGERY WAS PERFORMED ON (B)(6), 2019. THE PATIENT WAS NOW DOING WELL AND REPLACEMENT VALVE APPEARED TO BE PERFORMING NORMALLY.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9507657 ↗
• InjuryJul 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THE SURGEON DID NOT FEEL THERE WERE EXTERNAL/ENVIRONMENTAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE REPORTED ISSUE. IT WAS STATED THE PATIENT HAS PSEUDOTUMOR FOR WHICH THE DEVICE WAS INDICATED. FOLLOWING THE REPLACEMENT, THE PATIENT WAS DOING FINE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7654080 ↗
• MalfunctionMar 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PUMPING THE VALVE USING SALINE SOLUTION, LEAKING WAS FOUND AROUND THE RESERVOIR AND VALVE MECHANISM. THE VALVE WAS NEVER IMPLANTED AND WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361841 ↗
• InjuryAug 29, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE LUMBAR PERITONEAL (LP) SHUNT SYSTEM WAS IMPLANTED IN (B)(6) 2016. ACCORDING TO THE REPORT, THE PHYSICIAN STATED THAT THE VALVE PRESSURE VALUE WAS UNABLE TO BE CHANGED. REPORTEDLY, SINCE THE PHYSICIAN CONSIDERED THE EVENT WAS A PRODUCT MALFUNCTION ISSUE, A REVISION WAS PERFORMED TO REPLACE THE PRODUCT WITH ANOTHER MANUFACTURER'S DEVICE. AT THE TIME OF THE REPORT, THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6828162 ↗
• MalfunctionApr 21, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING SETUP, THE PHYSICIAN TRIED TO CHANGE THE PRESSURE SETTING FROM 2.0 TO 2.5 BUT WAS UNABLE TO DO SO. ACCORDING TO THE REPORT, ANOTHER PERSON TRIED AGAIN, BUT IT DIDN'T WORK. REPORTEDLY, THE DEVICE WAS NEVER IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6511761 ↗
• InjuryFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS REMOVED AS PART OF A SHUNT EXPLANT. ACCORDING TO THE REPORT, THE PATIENT WAS UNDER FOLLOW-UP.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6299076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123524. 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