NA 44513Recalls & reported problems
Medtronic Ps Medical, Inc. · RES 44513 CSF-LUMBOPERITONEAL RES 20MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00673978228471), received between May 30, 2018 and Jun 21, 2019 — classified as 4 malfunctions.
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
- Appropriate Device Problem Term/Code Not Available4
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT PREOPERATIVELY, THE DOCTOR FOUND THE LUMBOPERITONEAL RESERVOIR WAS OCCLUDED WHEN TESTED. ACCORDING TO THE REPORT, THE PATIENT WAS IMPLANTED WITH A LUMBOPERITONEAL CATHETER AND THE PATIENT¿S CURRENT STATUS IS NORMAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8722241 ↗MalfunctionJun 21, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT PREOPERATIVELY, THE DOCTOR FOUND THE LUMBOPERITONEAL RESERVOIR WAS OCCLUDED WHEN TESTED. ACCORDING TO THE REPORT, THE PATIENT WAS IMPLANTED WITH A LUMBOPERITONEAL CATHETER AND THE PATIENT¿S CURRENT STATUS IS NORMAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8722240 ↗MalfunctionMay 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THE PHYSICIAN WAS GOING TO DO AN ABDOMINAL CAVITY SHUNT OPERATION; HOWEVER, THE RESERVOIR WAS FOUND TO BE PLUGGED DURING THE PRE-OPERATION TEST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7554966 ↗MalfunctionMay 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THE PHYSICIAN WAS GOING TO DO AN ABDOMINAL CAVITY SHUNT OPERATION; HOWEVER, THE RESERVOIR WAS FOUND TO BE PLUGGED DURING THE PRE-OPERATION TEST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7554949 ↗
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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