CODMAN® HAKIM® 823854Recalls & reported problems
Integra Lifesciences Production Corporation · Programmable Valve In-line Valve SIPHONGUARD™ Device, 0.060'' platform and Unitized Distal Catheter · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780535119), received between Nov 15, 2024 and Nov 15, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (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.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Program or Calibrate1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.