N/A 44406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994653352), received between Feb 2, 2017 and Nov 29, 2017 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K123524); 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.

• 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 PERITONEAL (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 7068852 ↗
• InjuryAug 29, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE LUMBAR PERITONEAL (LP) SHUNT SYSTEM WAS IMPLANTED IN (B)(6) 2016. ACCORDING TO THE REPORT, THE PHYSICIAN SUSPECTED THAT THE LUMBAR VERTEBRA CATHETER WAS OCCLUDED. REPORTEDLY, SINCE THE PHYSICIAN CONSIDERED THE EVENT WAS A PRODUCT MALFUNCTION ISSUE, A REVISION WAS PERFORMED TO REPLACE THE PRODUCT WITH ANOTHER MANUFACTURER'S DEVICE. AT THE TIME OF THE REPORT, THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6828182 ↗
• InjuryFeb 2, 2017Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE LEAKED CEREBROSPINAL FLUID. ACCORDING TO THE REPORT, THERE WAS PATIENT IMPACT DUE TO THIS, BUT THE NATURE OF THE IMPACT WAS UNOBTAINABLE. REPORTEDLY, THE DEVICE WAS EXPLANTED AND A PERFORATION WAS FOUND ON THE DEVICE. IT WAS STATED THE PATIENT WAS UNDER FOLLOW-UP.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6299013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123524. 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