Strata® 46856 (UDI 00763000027506)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000027506), received between Oct 18, 2022 and Oct 18, 2022 — classified as 1 injury.

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

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO USE THE TUNNELER FROM SITE OF THE RIGHT SUPERIOR NECK TO A CLAVICLE CUT DOWN. WHEN ADVANCING THE PASSER WITH GREAT DIFFICULTY DUE TO PASSER TENSION AND TISSUE, IT WAS DISCOVERED THAT THE PLASTIC INNER CANNULA TIP HAD BROKEN OFF AND WAS LOST IN PATIENT TISSUE. THIS WAS FOUND THAT AFTER MULTIPLE ATTEMPTS TO PASS THROUGH THE TISSUE. THE SURGEON TRIED TO LOCATEFOR APPROXIMATELY 1 HOUR WHILE TRYING TO COMPLETE PROCEDURE, BUT WAS UNABLE TO LOCATE THE TIP. THEY ALSO TRIED FLUOROSCOPY. IT WAS NOTED THAT THIS DIDN¿T HAPPEN WITH THE OTHER PASSER. THE SURGEON ATTEMPTED TO USE PASSER TO RETRIEVE SILK TIE TO FEED DISTAL CATHETER TO PERITONEUM. IT WAS NOTED THAT THE SUSPECTED CAUSE OF THE ISSUE WAS THAT WHILE TRYING TO TURN AND MANIPULATE THE PASSER, PULLING, AND TURNING THE PASSER HANDLE TWISTED THE TIP WITH SIGNIFICANT LEGATE TO SEPARATE TIP FROM REST OF THE PLASTIC CANNULA. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF AT LEAST 60 MINUTES. THERE WAS NO OTHER REPORTED IMPACT TO THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15625797 ↗

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