Strata®, BioGlide® 27819Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169010499), received between Dec 15, 2016 and Dec 16, 2018 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PATENCY CHECK, THE PHYSICIAN FOUND THAT THE DELTA CHAMBER LEAKED. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8167905 ↗
• MalfunctionFeb 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PRIOR TO IMPLANT, THE FLUSHING OF THE SHUNT FAILED WHEN PUMPING THE RESERVOIR. IT WAS STATED THE SHUNT WAS CONSIDERED TO HAVE AN ANOMALY AND WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7245625 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT¿S ABDOMEN WAS COVERED WITH FLUID AND THERE WAS A SUSPECTED INFECTION ABOUT 3 MONTHS AFTER IMPLANT. THE DEVICE WAS EXPLANTED. A CULTURE INDICATED THERE WERE INFLAMMATORY CHANGES AND AN EPIDERMIS INFECTION. THE PATIENT¿S STATUS WAS NOTED AS ALIVE-NO INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 7144189 ↗
• MalfunctionNov 27, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING SURGERY, THE BOTTOM OF THE RESERVOIR LEAKED WHEN THE PHYSICIAN SQUEEZED THE RESERVOIR. THE PRODUCT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060939 ↗
• InjurySep 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE POOR EFFECT WAS POOR VALVE DIVERSION.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6889299 ↗
• MalfunctionJun 28, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE SHUNT SYSTEM MALFUNCTIONED, AND THE USE OF IT WAS STOPPED. ACCORDING TO THE REPORT, ALTHOUGH THE RESERVOIR OF THE VALVE WAS PUMPED, THERE WAS NO CEREBROSPINAL FLUID. IT WAS STATED THAT THE EVENT OCCURRED WHEN THE BOTH THE PRODUCTS WERE CONNECTED, AND IT WAS UNKNOWN AT PRESENT WHICH DEVICE WAS NOT WORKING. REPORTEDLY, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6674189 ↗
• InjuryJun 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER SEVERAL REGULATORY PRESSURES, THE SHUNT EFFECT WAS STILL NOT OBVIOUS, AND THE PATIENT'S CONDITION DID NOT DECREASE. ACCORDING TO THE REPORT, THE PATIENT WAS RELIEVED WHEN THE VALVE WAS REPLACED, AND THE DOCTOR SUSPECTED A VALVE FAILURE.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6664086 ↗
• MalfunctionJun 16, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE PROCEDURE, THE VALVE WAS FOUND TO BE LEAKING AFTER BEING SQUEEZED. ACCORDING TO THE REPORT, THERE WAS A HOLE IN THE MIDDLE OF THE VALVE. IT WAS STATED THE PHYSICIAN DID NOT CHECK THE VALVE BEFORE SURGERY. REPORTEDLY, THE VALVE WAS REPLACED TO COMPLETE THE PROCEDURE AND THERE WAS NO IMPACT TO THE PATIENT. THE PATIENT¿S STATUS WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6647925 ↗
• InjuryJun 15, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DISEASE EXPECTED TO BE TREATED WAS CRANIOCEREBRAL TRAUMA. ACCORDING TO THE REPORT, ON (B)(6) 2017, THE PATIENT HAD RIGHT BRAIN SKULL REPAIR AND LEFT BRAIN SHUNT PLACEMENT. BEFORE THE SURGERY, THE PATIENT'S LUMBAR PUNCTURE PRESSURE WAS 300, AND THE IMPLANTED VALVE PRESSURE WAS SET AT 2.5. AFTER 2 DAYS, THE VENTRICLE DIDN'T DECREASE, AND THE PHYSICIAN ADJUSTED THE PRESSURE TO 2.0 ON (B)(6) 2017. IT WAS STATED THE VENTRICLE STILL DIDN'T REDUCE. ON (B)(6), 2017, THE PHYSICIAN ADJUSTED THE PRESSURE TO 1.5, BUT THE FILM SHOWED NO REDUCTION IN CEREBROSPINAL FLUID. ON (B)(6) 2017, THE PHYSICIAN ADJUSTED THE PRESSURE TO 1.0 BUT WAS STILL INEFFECTIVE. ON (B)(6) THE PHYSICIAN FINALLY ADJUSTED THE PRESSURE TO 0.5. REPORTEDLY, DURING THIS PERIOD, THE PRESSURE WAS NORMAL. THE PATIENT'S FAMILY REPEATEDLY PRESSED THE VALVE POSITION, AND THE ELASTICITY OF THE VALVE WAS GOOD. THE PHYSICIAN PRESSED THE VALVE POSITION, AND THE ELASTICITY WAS GOOD AND BOTH ENDS OF THE CATHETER WERE NOT BLOCKED, BUT THERE WAS NOT NORMAL DRAINAGE. THE PATIENT WASN'T IMPROVING, AND THE DOCTOR MEASURED THE LUMBAR PUNCTURE PRESSURE TO BE AT 400 ON (B)(6) 2017. IT WAS STATED

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6645067 ↗
• MalfunctionFeb 10, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS IMPLANTED DUE TO HYDROCEPHALUS. ACCORDING TO THE REPORT, THE DEVICE LEAKED INTRA-OPERATIVELY. REPORTEDLY, THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6322103 ↗
• MalfunctionDec 15, 2016Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CEREBROSPINAL FLUID DID NOT FLOW NORMALLY WITH SETTING PRESSURE PRIOR TO USE. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED WITH A NEW DEVICE TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6179635 ↗

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