Strata™ 44420Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169975866), received between Feb 6, 2018 and Jun 1, 2021 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K123524); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2021Break; Break

  IT WAS REPORTED THAT WHEN THE GUIDE WIRE WAS USED TO REINFORCE THE TOUGHNESS OF THE LUMBOSACRAL END, BREAKAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913532 ↗
• InjuryMar 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  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

  MAUDE report 11406475 ↗
• MalfunctionNov 19, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SHUNT WAS NOT EXPLANTED, AND THE PATIENT WAS STILL SICK. THERE WERE NO ENVIRONMENT AL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT WAS GIVEN THE MEDICATION DAIMOX250.

  Patient problems: Malaise; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10869152 ↗
• InjuryAug 21, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOWING SYMPTOMS OF UNDERDRAINAGE. THE VALVE WAS EXPLANTED AND REPLACED WITH A NEW ONE.

  Patient problems: Insufficient Information; Therapeutic Effects, Unexpected

  MAUDE report 10438618 ↗
• MalfunctionJun 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CSF MANAGEMENT SURGERY. IT WAS REPORTED THAT THE WATER STORAGE VALVE REBOUND FUNCTION WAS POOR. THERE WAS NO INTERVENTION PERFORMED OR PLANNED RELATED TO THE ISSUE. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692760 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE VALVE REBOUND FUNCTION WAS NOT GOOD AND IT HAD POOR ELASTICITY. THE DEVICE WAS EXPLANTED, AND THE PATIENT'S STATUS WAS ALIVE NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8558175 ↗
• InjuryMar 14, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE VALVE HAD POOR ELASTICITY. IT WAS STATED THE RESERVOIR REBOUND SPEED WAS SLOW DURING THE PRE-OPERATIVE TEST. AFTER IMPLANTATION, NO FUNCTION WAS FOUND. THE VALVE WAS EXPLANTED AND REPLACED. 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 8423164 ↗
• InjuryFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE VALVE WAS NOT FLEXIBLE AND REBOUNDED SLOWLY. THE VALVE WAS EXPLANTED, AND THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8358830 ↗
• MalfunctionJan 11, 2019Break; Break

  IT WAS REPORTED THE END OF THE CATHETER BROKE DURING THE PROCEDURE. THE PRODUCT WAS NOT USED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8241873 ↗
• InjurySep 7, 2018Disconnection; Disconnection

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PER THE PHYSICIAN, THE PATIENT WEIGHT COULD HAVE BEEN A CONTRIBUTING FACTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855447 ↗
• MalfunctionAug 15, 2018Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DRAINAGE WAS NOT SMOOTH. IT WAS STATED "AFTER THE OPERATION, THE LINE WAS NOT LOOSENED DURING THE OPERATION, BUT THE WATER WAS LEAKING ON THE WOUND." IT WAS SUSPECTED THAT THE RESERVOIR WAS BLOCKED AND LEAKED. 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 7786162 ↗
• MalfunctionJun 19, 2018Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  IT WAS REPORTED THE RESERVOIR DID NOT FUNCTION WELL. THE DEVICE WAS NEVER IMPLANTED. 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 7614461 ↗
• MalfunctionMar 14, 2018Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT AFTER THE LUMBAR CATHETER / DRAIN PLACEMENT, IT WAS NOTICED THAT SPINAL FLUID WAS LEAKING FROM A SUPPOSED HOLE IN THE SIDE OF THE CATHETER. THE DEVICE WAS REPLACED AND IT WAS CONFIRMED THAT THE SECOND CATHETER DID NOT LEAK.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7339331 ↗
• InjuryFeb 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT¿S LUMBAR SPINE WOULD APPEAR CONVEX. IT WAS STATED THAT THE BULGE WOULD DISAPPEAR WHEN CEREBROSPINAL FLUID (CSF) WAS TAKEN FROM THE VALVE AND THE PRESSURE DECREASED. HOWEVER, THE SITUATION WOULD REAPPEAR, AND OBSTRUCTION WAS NOTED. THE WOUND WAS OPENED TO DO A LUMBAR PUNCTURE AND THERE WERE NO ABNORMALITIES. IT WAS NOTED A CSF INFECTION WAS FOUND. THE DEVICE WAS EXPLANTED, AND THE PATIENT¿S STATUS WAS LISTED AS NO INJURY.

  Patient problems: Complaint, Ill-Defined; Unspecified Infection

  MAUDE report 7245989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123524. 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