Strata®, BioGlide® 96665Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169472938), received between Dec 6, 2016 and Nov 29, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K033850); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS THAT DURING THE PROCEDURE, FLUID SUCH AS CEREBROSPINAL FLUID (CSF) DID NOT DRAIN SMOOTHLY WHEN PUMPING WAS PERFORMED USING CSF AND SALINE. THEREFORE, THE USE OF THE DEVICES WERE DISCONTINUED. PER THE PHYSICIAN, THE FLOW BACK FROM THE RESERVOIR WAS SLOW AND DISCHARGE OF THE CSF COULD NOT BE OBSERVED. AS FURTHER DIFFICULTIES WERE EXPECTED IN CHECKING THE DEVICE OPERATION ONCE THEY WERE PLACED SUBCUTANEOUSLY, THE USE OF THE DEVICES WERE DISCONTINUED. AFTER IMPLANTING A PART OF THE LUMBAR CATHETER IN THE PATIENT, A BACKUP LUMBAR PERITIONEAL (LP) SHUNT WAS UNPACKED AND CONNECTED WITH THE LUMBAR CATHETER AND LP VALVE, AND FURTHER CONNECTED WITH THE LP SHUNT. IT WAS NOTED THAT THE PROXIMAL EDGE OF THE LUMBAR CATHETER HAD REMAINED INSIDE THE PATIENT'S BODY. THE DISTAL EDGE WAS EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068834 ↗
• InjuryDec 6, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE HAD MALFUNCTIONED. IT WAS STATED THAT OCCLUSION/DAMAGE WAS CONSIDERED. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6147470 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033850. 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