NA 9003 ERecalls & reported problems
Medtronic Ps Medical, Inc. · KIT 9003 E SHUNT INTL ONLY CONT REG M · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169466371), received between Jul 14, 2017 and Mar 7, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break3
- Fluid/Blood Leak1
- Fracture1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2021Break; Fracture; Break; Fracture
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11426527 ↗MalfunctionAug 2, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PERMEABILITY OF THE VALVE WAS TESTED, AND A LEAK WAS DETECTED. THIS RESULTED IN A 20 MIN DELAY IN THE PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8855658 ↗MalfunctionMar 11, 2019Break; Break
IT WAS REPORTED THE DEVICE WAS FOUND TO BE BROKEN WHEN OPENING THE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8408633 ↗MalfunctionNov 28, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING SURGERY, THE VALVE WAS LEAKING AT THE EDGE OF THE RESERVOIR. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7063633 ↗MalfunctionJul 14, 2017Break; Break
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE HAD A HOLE IN THE CEREBROSPINAL FLUID (CSF) FLOW OUTPUT AND WAS FOUND INTR A-OPERATIVELY. ACCORDING TO THE REPORT, THE DOCTOR USED ANOTHER VALVE TO COMPLETE THE SURGERY. REPORTEDLY, THERE WAS NO INJURY, AND THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6715551 ↗
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
- 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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