NA 11-0401-CERecalls & reported problems
Medtronic Ps Medical, Inc. · KIT 11-0401-CE SEPS OUS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994505217), received between Sep 11, 2024 and Sep 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K002970, K042359); 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION REGARDING A SUBDURAL EVACUATION PORT SYSTEM (SEPS). IT WAS REPORTED THAT DURING INSERTION OF A DEEP VEIN THROMBOSIS (DVE), THE NEUROSURGERY INTERN EXPERIENCED DIFFICULTY IN KEEPING THE SKIN RETRACTORS OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191335 ↗MalfunctionSep 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SITE CHANGED THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191095 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K002970, K042359. One submission often covers many models, so check the product and lot details in each record.
- Z-0551-2014 · Nov 26, 2013 · TerminatedIntegra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of th
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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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