Strata™ 42335Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169975781), received between Oct 22, 2018 and Oct 14, 2021 — classified as 1 injury, 3 malfunctions.

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 (K082127); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2021Mechanics Altered; Mechanics Altered

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SETTING WAS NOTICED TO HAVE BEEN ADJUSTED UNKNOWINGLY. THE NURSE CLINICIAN SUSPECTED THAT IT WAS THE MAGNET FROM THE WRIST BAND AS THE MAIN CAUSE FOR THE ISSUE AS IT WAS A COMMON ACCESSORY WHICH WARD NURSESMCARRY ALONG WITH THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634812 ↗
• MalfunctionFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE VALVE'S FLEXIBILITY WAS POOR INTRA-OPERATIVELY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358883 ↗
• MalfunctionDec 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DRAINAGE VALVE HAD POOR ELASTICITY. THE VALVE WAS NEVER IMPLANTED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8170707 ↗
• InjuryOct 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991267 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082127. One submission often covers many models, so check the product and lot details in each record.

• 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