Strata® 42355 (UDI 00763000028404)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000028404), received between Jun 2, 2023 and Nov 20, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS PROGRAMMED TO 2.0 AND SENT HOME AS THEIR SYMPTOMS WERE RESOLVING.

  Patient problems: Insufficient Information

  MAUDE report 23606081 ↗
• MalfunctionMay 28, 2024Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THE VALVE WOULD NOT PROGRAM. THE ISSUE WAS FOUND BEFORE THE CASE STARTED, AND THERE WAS NO IMPACT TO THE PATIENT OR ANYONE ELSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404491 ↗
• MalfunctionMay 14, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THAT DURING THE SURGERY, AFTER PLACING THE VENTRICULAR CATHETER, AND THE CEREBROSPINAL FLUID (CSF) DRAINAGE WAS HIGH, THE VALVE WAS INSERTED, BUT THERE WAS NO FLOW AFTER 7 MINUTES. THE PRESSURE WAS ADJUSTED, HOWEVER, THERE WAS STILL NO DRAINAGE. THE VALVE WAS REPLACED WITH A NEW ONE AT THE SAME PRESSURE, AND THERE WAS GOOD CSF FLOW FROM THE VALVE. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309252 ↗
• InjuryApr 12, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED ON (B)(6) 2024, AND IT WAS WORKING NORMALLY. AFTER TWO WEEKS, THE SURGEON NOTICED THAT THERE WAS NO CLINICAL IMPROVEMENT, AND THE VENTRICULAR PRESSURE WAS STILL HIGH AS IT HAD BEEN BEFORE SURGERY. AFTER THE CT CONTROL, ALL VALVE CONNECTIONS WERE CORRECT, AND THERE WERE NO CHANGES AFTER THE PRESSURE WAS ADJUSTED. THE SURGEON DECIDED TO PERFORM A SURGERY TO SEE WHAT THE WAS ON. IT APPEARED THAT THE VALVE DID NOT WORK CONSTANTLY, AND THE FLOW WAS DISCONTINUED. THE VALVE WAS REMOVED ON (B)(6) 2024 AND WAS REPLACED WITH ANOTHER ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19098587 ↗
• MalfunctionJun 2, 2023Mechanics Altered; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A VALVE. IT WAS REPORTED THE VALVE WAS NOT REMAINING AT THE PERFORMANCE LEVEL THAT THE PHYSICIAN WAS TRYING TO SET IT TO. THE ISSUE WAS FOUND DURING PRE-OP AND THE DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050601 ↗

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