NA 9040 DRecalls & reported problems
Medtronic Ps Medical, Inc. · KIT 9040 D SHUNT INTL ONLY BH 16MM LOW · Class 2 · Implant
- 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 00643169472730), received between Oct 23, 2019 and Jan 23, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K831678); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Insufficient Device Problem Information1
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 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SURGEON STATED THAT THE SHUNT DEVICE WAS UNABLE TO PURGE WATER DURING THE PRE-IMPLANTATION TEST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9624196 ↗MalfunctionJan 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SURGEON STATED THAT THE SHUNT DEVICE WAS UNABLE TO PURGE WATER DURING THE PRE-IMPLANTATION TEST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9624192 ↗MalfunctionOct 23, 2019Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE VALVE MALFUNCTIONED BEFORE THE DOCTOR USED IT ON THE PATIENT. IT WAS STATED THE FLUID COULD NOT FLOW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9226437 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K831678. 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
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.