Strata® 42365 (UDI 00643169466111)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169466111), received between Jan 20, 2017 and Jul 20, 2018 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2018Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A CEREBRAL PERITONEAL SHUNT ON (B)(6) 2018 DUE TO SUDDEN HYDROCEPHALUS AFTER A TRAUMA. DURING THE OPERATION, THERE WERE NORMAL CONNECTIONS BETWEEN THE VENTRICLE AND THE ABDOMINAL END CATHETER, BUT AFTER PRESSING THE VALVE RESERVOIR, A SMALL AMOUNT OF CEREBROSPINAL FLUID EXUDATE AT THE END OF THE VALVE. THE VALVE WAS REPLACED IMMEDIATELY. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY.

  Patient problems: Cerebrospinal Fluid Leakage; No Known Impact Or Consequence To Patient

  MAUDE report 7706535 ↗
• InjuryJan 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO OBSTRUCTION. THE PATIENT¿S STATUS WAS LISTED AS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7182096 ↗
• InjuryDec 6, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THE VALVE WAS BLOCKED. THE VALVE WAS EXPLANTED AND THE PATIENT¿S STATUS WAS NOTED AS NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7087623 ↗
• InjuryNov 3, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THE VALVE WAS CLOGGED. THE VALVE WAS EXPLANTED AND REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6998577 ↗
• MalfunctionSep 6, 2017Mechanical Jam; Mechanical Jam

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED HAT THE PATIENT RETURNED TO THE EMERGENCY ROOM SO THE SURGEON CHANGED THE VALVE FROM 1.0 TO 1.5. THE REP CONFIRMED THE SETTINGS WERE UPDATED TO 1.5. AN X-RAY WAS THEN PERFORMED THAT ALSO CONFIRMED THE RESULTS.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6847032 ↗
• MalfunctionJun 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT WHEN THE SURGEON DID THE ROUTINE TESTING FOR THE VALVE, THEY FOUND OUT THAT THE VALVE REBOUNDED SLOWLY. ACCORDING TO THE REPORT, THE REFLEXIBILITY OF VALVE WAS NOT GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6655466 ↗
• InjuryApr 19, 2017Break; Inaccurate Flow Rate; Appropriate Device Problem Term/Code Not Available; Break; Inaccurate Flow Rate; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS IMPLANTED DUE TO HYDROCEPHALUS ON (B)(6) 2017. ACCORDING TO THE REPORT, ON THE DAY FOLLOWING IMPLANT, THE DEVICE SHOWED POOR DRAINAGE. THE PATIENT HAD AN X-RAY WHICH SHOWED THAT THE RESERVOIR WAS DAMAGED. REPORTEDLY, THE DEVICE WAS REPLACED ON (B)(6) AND THE PATIENT¿S STATUS WAS WELL.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6504430 ↗
• MalfunctionMar 10, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE RESERVOIR LEAKED DURING PRE-IMPLANTATION TESTING. ACCORDING TO THE REPORT, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6395023 ↗
• MalfunctionJan 20, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS OBSTRUCTED INTRA-OPERATIVELY. ACCORDING TO THE REPORT, ANOTHER DEVICE WAS USED TO COMPLETED THE PROCEDURE. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6268074 ↗

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