Strata® 27816 (UDI 00643169010529)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169010529), received between Jul 19, 2017 and May 20, 2019 — classified as 1 death, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS HISTORY OF MATERNAL CHORIOAMNIONITIS AND PRESUMED NEONATAL MENINGITIS. SERIAL ULTRASOUNDS DEMONSTRATED GRADE IV INTRAVENTRICULAR HEMORRHAGE WITH INCREASING HYDROCEPHALUS. ULTRASOUND ON (B)(6) 2017 NOTED SIGNIFICANT INCREASE IN VENTRICULAR DILATATION WITH RESIDUAL BLOOD PRODUCTS IN BOTH LATERAL VENTRICLES. ON (B)(6) 2017, A RIGHT FRONTAL INSERTION OF VENTRICULAR CATHETER WITH SUBCUTANEOUS RESERVOIR WAS PLACED WHEN THE INFANT REACHED A WEIGHT OF (B)(6), TO HELP PERIODICALLY DRAIN CSF. THERE WERE NO COMPLICATIONS AND THE BABY WAS IN STABLE CONDITION AFTER THE PROCEDURE. ON (B)(6) 2017, WHEN THE INFANT WIGHT WAS ABOVE 2500 GRAMS, THE RIGHT FRONTAL VENTRICULAR CATHETER RESERVOIR WAS REMOVED AND A VENTRICULOPERITONEAL SHUNT WAS PLACED. AGAIN THERE WERE NO COMPLICATIONS AND THE BABY TOLERATED THE PROCEDURE WELL. NOT LONG AFTER THE VENTRICULOPERITONEAL SHUNT PLACEMENT, CULTURES OF THE CSF FROM A SHUNT TAP (COLLECTED (B)(6) 2017) GREW GRAM NEGATIVE BACILLI, SPECIFICALLY SERRATIA MARCESCENS, CONSISTENT WITH VP SHUNT INFECTION. HE WAS GIVEN BROAD SPECTRUM ANTIBIOTICS, NEUPOGEN AND IVIG; HOWEVER, HE CONTINUED TO HAVE WORSENING NEUTROPENIA

  Patient problems: Abnormal Blood Gases; Bacterial Infection; Cardiac Arrest; Complaint, Ill-Defined; Death; Septic Shock

  MAUDE report 8625868 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE INFECTION WAS UNKNOWN. IT WAS ALSO STATED THE INFECTION WAS SEPSIS. THE CURRENT STATUS OF THE PATIENT WAS REPORTEDLY UNKNOWN.

  Patient problems: Inflammation; Sepsis; Staphylococcus Aureus

  MAUDE report 7108426 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE INFECTION WAS UNKNOWN. IT WAS ALSO STATED THE INFECTION WAS SEPSIS. THE CURRENT STATUS OF THE PATIENT WAS REPORTEDLY UNKNOWN.

  Patient problems: Inflammation; Sepsis; Staphylococcus Aureus

  MAUDE report 7108385 ↗
• MalfunctionDec 12, 2017Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available; Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PERITONEAL CATHETER WAS BLOCKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7108339 ↗
• MalfunctionDec 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT WHILE STILL IN THE STERILE PACKAGING, THE SURGEON WAS HAVING DIFFICULTY ADJUSTING THE DEVICE TO THE APPROPRIATE SETTINGS. IT WAS STATED THE SETTING ¿ENDED UP BETWEEN.¿ THE DEVICE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088910 ↗
• InjuryOct 9, 2017Inaccurate Flow Rate; Device Operates Differently Than Expected; Inaccurate Flow Rate; Device Operates Differently Than Expected

  IT WAS REPORTED THE SHUNT WAS NOT FUNCTIONING AND WAS REPLACED WHERE THE VALVE INCLUDING THE VENTRICULOSTOMY DOME AND APPROXIMATELY 2CM OF THE PERITONEAL CATHETER WAS EXPLANTED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6930220 ↗
• InjuryJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT ON (B)(6) 2017, THE PHYSICIAN'S NOTES SHOWED THEY LEFT THE NEW VALVE AT THE PRIOR SETTING, BUT THE PATIENT WAS NOTED TO HAVE HYDROCEPHALUS. REPORTEDLY, THE PATIENT WENT TO SURGERY ON (B)(6) 2017 AND HAD A VENTRICULOPERITONEAL (VP) SHUNT REVISION. THE PHYSICIAN'S OPERATIVE NOTE STATED THEY DECIDED TO REPLACE THE VALVE AND CHANGE THE SETTING AS WELL AS REPLACE THE PROXIMAL CATHETER WITH ANOTHER CATHETER.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6725970 ↗
• InjuryJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS ADMITTED WITH A VENTRICULOPERITONEAL (VP) SHUNT MALFUNCTION. ACCORDING TO THE REPORT, THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2017 FOR VP SHUNT REVISION. THE SURGEON FOUND THE VALVE NOT TO BE WORKING, SO THE DEVICE WAS REPLACED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6725852 ↗

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