NA 43555Recalls & reported problems
Medtronic Ps Medical, Inc. · CATHETER 43555 PERITONEAL SMALL LUMEN · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169466807), received between Feb 2, 2017 and Aug 24, 2018 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
- Occlusion Within Device1
Patient problems
- No Known Impact Or Consequence To Patient2
- Bacterial Infection1
- Cerebrospinal Fluid Leakage1
- Hepatitis1
- Therapeutic Response, Decreased1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2018Fracture; Fracture
IT WAS REPORTED THE CATHETER WAS BROKEN DURING THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7813243 ↗InjuryJul 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED REPORTED THE SURGEON DID NOT FEEL THERE WERE EXTERNAL/ENVIRONMENTAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE REPORTED ISSUE. IT WAS STATED THE PATIENT HAS PSEUDOTUMOR FOR WHICH THE DEVICE WAS INDICATED. FOLLOWING THE REPLACEMENT, THE PATIENT WAS DOING FINE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 7654082 ↗InjuryNov 27, 2017Occlusion Within Device; Occlusion Within Device
ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE INFECTIONS WAS UNKNOWN, HOWEVER IT WAS NOTED THE INFECTIONS WERE NOT RELATED TO THE DEVICE. THE PATIENT UNDERWENT AN IMPLANT OF A VENTRICULOPERITONEAL SHUNT IN LATE JANUARY 2018. THE PATIENT¿S STATUS WAS GOOD.
Patient problems: Bacterial Infection; Hepatitis; No Known Impact Or Consequence To Patient
MAUDE report 7060663 ↗InjuryFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS REMOVED AS PART OF A SHUNT EXPLANT. ACCORDING TO THE REPORT, THE PATIENT WAS UNDER FOLLOW-UP.
Patient problems: Therapeutic Response, Decreased
MAUDE report 6298970 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- 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
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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