NA 42534Recalls & reported problems
Medtronic Ps Medical, Inc. · VALVE 42534 BURR HOLE 12MM MED PRESS IMP · Class 2 · Implant
Data updated Oct 13, 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 00643169466067), received between Aug 9, 2017 and Sep 13, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Inaccurate Flow Rate” (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
- Inaccurate Flow Rate3
- Appropriate Device Problem Term/Code Not Available1
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.
MalfunctionSep 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT PRE-OPERATIVELY THERE WAS NO FLOW THROUGH THE VALVE. THE CAUSE WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT AND THE VALVE WAS REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7872800 ↗MalfunctionOct 20, 2017Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THERE WAS NO FLOW THROUGH THE VALVE WHEN THE NURSE DID THE TESTING PRIOR TO IMPLANT. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6964482 ↗MalfunctionOct 20, 2017Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THERE WAS NO FLOW THROUGH THE VALVE WHEN THE NURSE DID THE TESTING PRIOR TO IMPLANT. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6964480 ↗MalfunctionAug 9, 2017Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS BROKEN AND COULD NOT EFFECTIVELY DRAIN BEFORE IT WAS IMPLANTED. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6777374 ↗
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
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- 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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