Strata® 44410Recalls & reported problems
Medtronic Ps Medical, Inc. · CATH 44410 LUMBOPERITONEAL SYSTEM IMP · Class 2 · Implant
All models of Strata (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000027247), received between Jan 23, 2023 and Jun 26, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR A LUMBAR SACRAL PERITONEAL SHUNT IMPLANTATION, AND BEFORE THE OPERATION, THE DEVICE PACKAGING WAS OPENED, AND THE CATHETER WAS FOUND TO BE BROKEN. THE DEVICE WAS REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22335190 ↗MalfunctionMar 27, 2023Complete Blockage; Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT DEVICE WAS NOT WORKING PROPERLY. THE SURGERY WAS POSTPONED UNTIL (B)(6). THE SHUNT WAS WORKING. THE CATHETER WAS NOT ADVANCING, HANGING APPROXIMATELY 1MM OF "CONSTRUCTION" AND SEEMED TO BE ADVANCING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16620513 ↗InjuryJan 23, 2023Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING A DRAINAGE SYSTEM. IT WAS REPORTED THAT WHEN FIXATING THE FIXATION TAB, THE DRAIN BROKE OFF. THE DRAIN WAS REMOVED COMPLETELY AND THEY HAVE PLACED A NEW ONE. THERE WAS A REPORTED DELAY OF 20 MINUTES AND IT WAS REPORTED THAT NO PIECES WERE LEFT IN THE PATIENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 16224171 ↗
Other Shunt, central nervous system and components devices
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- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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