Rivulet™ 41701Recalls & reported problems
Medtronic Ps Medical, Inc. · CATHETER 41701 RIVULET VENTRICULAR · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994480446), received between May 30, 2018 and May 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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
Device problems
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2018Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER THE STYLET WAS REMOVED FROM THE CATHETER, IT WAS UNABLE TO BE REINSERTED. IT WAS QUESTIONED IF THE CATHETER WAS BLOCKED. THE STYLET THAT WAS PACKAGED WITH THE CATHETER WAS THE SAME STYLET BEING USED. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7553595 ↗
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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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