NA 46624Recalls & reported problems
Medtronic Ps Medical, Inc. · SHUNT 46624 CSF ASSY SMALL MED CONT C/P · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169472457), received between May 8, 2019 and Jan 27, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K841442); 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.
Most reported problems
Device problems
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9633141 ↗MalfunctionMay 8, 2019Fracture; Fracture
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8592189 ↗MalfunctionMay 8, 2019Fracture; Fracture
IT WAS REPORTED THAT DURING IMPLANTATION, THE PERITONEAL CATHETER BROKE ABOUT 30 CENTIMETERS FROM THE DISTAL TIP DURING INSERTION. AFTER REINSERTING THE TUNNELER, THE PERITONEAL CATHETER WAS PASSED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8592170 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K841442. One submission often covers many models, so check the product and lot details in each record.
- Z-1117-2021 · Jan 11, 2021 · Open, ClassifiedMedtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY
- Z-0397-2014 · Nov 18, 2013 · TerminatedCSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Reg
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
- 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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