Strata™ 46866Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169975965), received between Dec 11, 2017 and Jan 22, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2024Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THE VALVE WAS EXPLANTED AS THE DOCTOR DID NOT FEEL THAT IT WAS FUNCTIONING PROPERLY. IT WAS STATED THAT THE DOCTOR ADJUSTED THE VALVE TO 0.5 WITH THE HAND TOOLS, BUT THE X-RAY VERIFICATION SHOWED THE VALVE AT 2.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552826 ↗
• MalfunctionFeb 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKING AT THE END OF THE SHUNT WHERE THE PERITONEAL END IS INTEGRALLY CONNECTED. THE SHUNT WAS NOT USED AND REPLACED AS A RESULT, WITH THE REPLACEMENT WORKING SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11316508 ↗
• MalfunctionApr 17, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT 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 9973015 ↗
• MalfunctionFeb 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9689762 ↗
• MalfunctionMay 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PRE-OPERATIVE PROCEDURE, AFTER OPENING THE SHUNT, THEY FLUSHED TO CHECK, AND VALVE WAS FOUND TO BE LEAKING. DUE TO THE VALVE LEAKING, BOTH THE VALVE AND CATHETER WERE NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8613672 ↗
• MalfunctionNov 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TESTING PRIOR TO IMPLANT, THE DELTA CHAMBER WAS FOUND TO BE LEAKING FROM THE DISTAL END. THE PRODUCT WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8071361 ↗
• MalfunctionMar 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRE-OPERATIVE TESTING, LEAKING FROM THE CHAMBER WAS OBSERVED. THE DEVICE WAS NOT USED AND WAS TO BE REPLACED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7349356 ↗
• InjuryDec 11, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT THE LEFT VENTRICULOPERITONEAL SHUNT FAILED POST-OPERATIVELY. THE VENTRICULAR CATHETER WAS SITUATED, AND THE DISTAL PERITONEAL END WAS IN PLACE, BUT THERE NO FLOW. THE SHUNT CHAMBER WAS CLOGGED WITH PROTEINACEOUS DEBRIS AND THIS WAS THE CAUSE OF THE FAILURE. THE DEVICE WAS EXPLANTED, AND THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7105588 ↗

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, Classified
  Medtronic 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 · Terminated
  Medtronic 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