Strata™ 27740Recalls & reported problems
Medtronic Ps Medical, Inc. · SHUNT 27740 STRATA NSC SNAP REG 120CM · Class 2 · Implant
All models of Strata (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169975569), received between Oct 8, 2018 and Oct 8, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Jam” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Mechanical Jam1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2018Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SHUNT WAS DEFECTIVE AND THE VALVE WOULD NOT ADJUST PRE-OPERATIVELY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7943595 ↗
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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- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · 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 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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