Strata™ 44465Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169975897), received between Feb 11, 2021 and Aug 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE LUMBOPERITONEAL VALVE. IT WAS REPORTED THAT THE SURGEON AND PATIENT STATED THAT THE VALVE FREQUENTLY LOST CALIBRATION. THEREFORE, THE SURGEON CLINICALLY DETERMINED THAT THE VALVE WAS NOT FUNCTIONING AND CONSIDERED EXPLANTATION AND PRODUCT REPLACEMENT, HOWEVER, THE VALVE REMAINED IN THE PATIENT AND AN INTERVENTION WAS NOT PERFORMED AT THIS TIME. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827279 ↗
• InjuryFeb 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING REVISION OF AN LP SHUNT AND INSERTION OF AN NSC STRATA VALVE. DURING PROCEDURE, THE VALVE WAS SET AT 1.5. ONE WEEK POST PROCEDURE THE PATIENT EXPERIENCED LOW PRESSURE HEADACHES, SO THE SETTING WAS INCREASED TO 2.0 THAT DAY, AND TO 2.5 TWO WEEKS LATER. THERE WAS NO CHANGE IN SYMPTOMS AT THE TIME. HOWEVER, ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED DURING WHICH A NEW VALVE WAS INSERTED, JUST TO CHECK WHETHER THE PREVIOUSLY VALVE WAS MALFUNCTIONING. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN NOTED THAT THE PATIENT IS STILL SHOWING SYMPTOMS, BUT THE NEW VALVE IS DEEMED FUNCTIONAL.

  Patient problems: Headache

  MAUDE report 11317155 ↗

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