Exacta™ 46710Recalls & reported problems
Medtronic Ps Medical, Inc. · BAG 46710 EXACTA DRAINAGE · Class 2
All models of Exacta (12)
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 00673978779539), received between Jun 7, 2024 and Jun 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage2
- Infusion or Flow Problem1
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.
MalfunctionJun 7, 2024Complete Blockage; Complete Blockage
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT CEREBROSPINAL FLUID (CSF) DID NOT FLOW INTO THE DRAINAGE BAG. THE SYSTEM WAS USED AFTER THE BAG WAS REPLACED, HOWEVER, THE SECOND DRAINAGE BAG SHOWED ISSUES WITH CSF FLUID PASSING THROUGH FROM THE SYSTEM TO THE DRAIN BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19488226 ↗MalfunctionJun 7, 2024Complete Blockage; Infusion or Flow Problem; Complete Blockage; Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT CEREBROSPINAL FLUID (CSF) DID NOT FLOW INTO THE DRAINAGE BAG. THE SYSTEM WAS USED AFTER THE BAG WAS REPLACED, HOWEVER, THE SECOND DRAINAGE BAG SHOWED ISSUES WITH CSF FLUID PASSING THROUGH FROM THE SYSTEM TO THE DRAIN BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487215 ↗
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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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