Strata® 42355 (UDI 00643169466920)Recalls & reported problems
Medtronic Ps Medical, Inc. · VALVE 42355 FP STRATA NSC SMALL · Class 2 · Implant
All models of Strata (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169466920), received between Apr 21, 2017 and Oct 5, 2018 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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
- Insufficient Device Problem Information2
- Mechanics Altered2
- Occlusion Within Device2
Patient problems
- No Known Impact Or Consequence To Patient4
- Hydrocephalus1
- Therapeutic Response, Decreased1
- Vomiting1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2018Mechanics Altered; Insufficient Device Problem Information; Mechanics Altered; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT EXHIBITED VOMITING, AND THE VALVE NEEDED TO BE READJUSTED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A FALL 3 DAYS BEFORE THE RE-ADJUSTMENT OCCURRED FROM 1 METER HEIGHT. IT WAS STATED THE DEVICE WAS RE-ADJUSTED FROM 1.5 WHERE IT WAS FOUND TO THE INITIAL 2.0. THE PATIENT WAS DOING GREAT WITHOUT ANY SYMPTOMS OR ANY OTHER SIGNS OF ADJUSTMENT ISSUES.
Patient problems: Vomiting
MAUDE report 7938826 ↗InjurySep 27, 2018Mechanics Altered; Insufficient Device Problem Information; Mechanics Altered; Insufficient Device Problem Information
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE VALVE WAS FOUND "INSTEAD OF 1.5 TO 2.0."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7915391 ↗InjuryAug 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THE VALVE WAS BLOCKED. THE VALVE WAS EXPLANTED AND THE PATIENT¿S STATUS WAS LISTED AS ALIVE ¿ NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7812435 ↗MalfunctionJan 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THE VALVE COULD NOT BE DRAINED OUT OF THE DISTAL END. THE NURSING STAFF AND PHYSICIANS REPORTEDLY TESTED THE VALVE ¿MANY TIMES¿ WITH NO SUCCESS. THE VALVE WAS NOT IMPLANTED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7212832 ↗InjuryOct 4, 2017Occlusion Within Device; Occlusion Within Device
IT WAS REPORTED THE PATIENT BEGAN EXPERIENCING SYMPTOMS OF HYDROCEPHALUS. THE SURGEON TESTED THE VALVE AND FOUND THAT IT WAS CLOGGED. THE VALVE WAS REPLACED.
Patient problems: Hydrocephalus; Therapeutic Response, Decreased
MAUDE report 6914175 ↗MalfunctionApr 21, 2017Occlusion Within Device; Occlusion Within Device
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE COULD NOT DRAIN THE CEREBROSPINAL FLUID INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THE SURGEON REMOVED THE VALVE FROM THE PATIENT AND TESTED THE VALVE'S FUNCTION BY SALINE. REPORTEDLY, THE VALVE WAS FOUND TO BE OBSTRUCTED. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6511701 ↗
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, ClassifiedMedtronic 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 · 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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