Strata™ 42355Recalls & reported problems
Medtronic Ps Medical, Inc. · VALVE 42355 FP STRATA NSC SMALL · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169975798), received between Oct 8, 2018 and Apr 17, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
- Infusion or Flow Problem1
- Mechanics Altered1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2020Infusion or Flow Problem; Infusion or Flow Problem
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9973225 ↗InjuryJan 8, 2020Mechanics Altered; Mechanics Altered
IT WAS REPORTED THE DOCTOR WAS HAVING ISSUES WITH THE VALVE. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE ISSUE WITH THE VALVE WAS THAT IT WAS AT A DIFFERENT SETTING THAN IT WAS ORIGINALLY SET AT. THE DOCTOR WAS CONCERNED IT WAS CHANGING ON ITS OWN/MALFUNCTIONING. THE VALVE WAS TAKEN OUT AND REPLACED. THEY WERE NOT AWARE OF ANY EXTERNAL FACTORS AFFECTING THE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9564411 ↗InjuryOct 8, 2018Break; Break
IT WAS REPORTED THERE WAS A CRACK IN THE PROXIMAL END OF THE PRESSURE VALVE. IT WAS STATED THE DEVICE WAS EXPLANTED, AND THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7943151 ↗
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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- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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