Strata® 42335Recalls & reported problems
Medtronic Ps Medical, Inc. · VALVE 42335 STRATA NSC BURR HOLE · Class 2 · Implant
All models of Strata (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994380104), received between Feb 8, 2017 and Nov 13, 2018 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Known Impact Or Consequence To Patient2
- Therapeutic Response, Decreased1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THE VALVE WAS UNABLE TO DRAIN DURING THE PROCEDURE. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8064328 ↗MalfunctionFeb 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS IMPLANTED IN (B)(6). ACCORDING TO THE REPORT, THE PATIENT WENT TO HAVE THE DEVICE CHECKED AND THE SETTING HAD CHANGED. REPORTEDLY, THE PATIENT HAD NOT BEEN NEAR ANY MAGNETIC FIELD THAT WOULD AFFECT THE CHANGE AND ONLY USED A CORDLESS PHONE.
Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Response, Decreased
MAUDE report 6313271 ↗
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 · TerminatedMedtronic 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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