Strata™ 42365Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169975804), received between Jan 23, 2018 and Jul 22, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED WHEN THE PRODUCT WAS OPENED ON THE OPERATING TABLE, THE DOCTOR APPLIED THE CATHETER TO THE DOCTOR TO TEST THE EXHAUST FUNCTION AND FOUND THAT THERE WAS A HOLE IN THE TOP OF THE VALVE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). 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 8812422 ↗
• InjuryJul 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD EXCESSIVE DRAINAGE AFTER A LAPAROTOMY. AFTER THE VALVE WAS REMOVED, THE DOCTOR FOUND THAT THE ACTUAL PRESSURE LEVEL OF THE VALVE WAS SIGNIFICANTLY LOWER THAN THE PRESSURE LEVEL OF THE VALVE ITSELF.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8798521 ↗
• MalfunctionApr 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE DOCTOR INSPECTED THE VALVE DURING THE OPERATION, THEY FOUND THAT THE RESERVOIR WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS, AND IT EXTENDED THE PROCEDURE BY 10 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8518732 ↗
• MalfunctionApr 16, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THE OUTLET END WAS BROKEN AND THE BOTTOM LEAKED ON THE VALVE PRE-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8518295 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THE VALVE CRACKED DURING THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210450 ↗
• MalfunctionJun 24, 2018Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE PACKAGE, THEY FOUND THAT THE RESERVOIR WAS DAMAGED. THE VALVE WAS NOT USED AND WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632780 ↗
• MalfunctionJan 23, 2018Break; Break

  IT WAS REPORTED THE VALVE WAS RUPTURED INTRA-OPERATIVELY. THE VALVE WAS NOT IMPLANTED AND THE PATIENT¿S STATUS WAS LISTED AS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7212124 ↗

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