Strata® 27815Recalls & reported problems
Medtronic Ps Medical, Inc. · SHUNT 27815 STRATA II ASSY REG · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000027568), received between Sep 6, 2024 and Sep 6, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE MARKERS (TWO DOTS AND ONE ARROW) WERE NOT VISIBLE IN X-RAY, SO IT WAS NOT POSSIBLE TO IDENTIFY FLOW DIRECTION AND SHUNT TYPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20158988 ↗MalfunctionSep 6, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED, THAT THE MARKERS (TWO DOTS AND ONE ARROW) WERE NOT VISIBLE IN X-RAY. SO, IT WAS NOT POSSIBLE TO IDENTIFY FLOW DIRECTION AND SHUNT TYPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20158934 ↗MalfunctionSep 6, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE MARKERS (TWO DOTS AND ONE ARROW) WERE NOT VISIBLE IN X-RAY, SO IT WAS NOT POSSIBLE TO IDENTIFY FLOW DIRECTION AND SHUNT TYPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20158924 ↗
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
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page