Strata® 46866 (UDI 00643169010680)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169010680), received between Mar 6, 2018 and Jun 14, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT HAD COMPLEX (VERY LOW PRESSURE) HYDROCEPHALUS POST-SUBARACHNOID HEMORRHAGE (SAH). AS PART OF THE PATIENT ¿S ADMISSION WITH THE SAH, THE PATIENT DID EXPERIENCE A LUNG INFECTION AND URINARY INFECTION. IT WAS STATED THE PATIENT NEEDED A NEAR ZERO PRESSURE SHUNT. THE PATIENT WAS IMPLANTED WITH SHUNT THAT WAS SET TO 0.5. REPORTEDLY, THE PATIENT FAILED TO IMPROVE AFTER IMPLANT AND WAS IN-PATIENT FOR ¿MANY WEEKS.¿ THE PATIENT ULTIMATELY PROCEEDED TO HAVE A LUMBAR DRAIN TO REMOVE MORE CEREBROSPINAL FLUID (CSF). THEY WERE SUBSEQUENTLY FOUND TO HAVE A CEREBROSPINAL FLUID INFECTION WHICH LED TO SHUNT REMOVAL/INSERTION OF THE DRAIN. AT THE SHUNT REMOVAL SURGERY, THE VALVE WAS TESTED (AT PRESSURE SETTING 0.5) AND FOUND TO HAVE SLOW FLOW AT 20 CM H2O, AND CEASED FLOWING AT 15 CM H2O.

  Patient problems: Therapeutic Effects, Unexpected; Unspecified Infection

  MAUDE report 7602442 ↗
• MalfunctionApr 10, 2018Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE VALVE BROKE IN HALF. IT WAS STATED THAT NO CAUSES OR EXTERNAL FACTORS WERE IDENTIFIED THAT MAY HAVE LED TO THE VALVE BREAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7416170 ↗
• MalfunctionMar 6, 2018Break; Break

  IT WAS REPORTED THE INSERT OF THE CATHETER PASSER INCLUDED IN THE SHUNT KIT SNAPPED AT THE TIP WHERE THE CATHETER WOULD BE CONNECTED. THIS HAPPENED WHEN THE SURGEON ATTEMPTED TO RELEASE THE INSERT TIP FROM THE HANDLE DURING THE PROCEDURE, PRIOR TO PATIENT CONTACT. IT WAS STATED NO EXCESS OR UNNECESSARY FORCE WAS OBSERVED. THE PRODUCT WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316393 ↗

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