InfraVision 0220180517Recalls & reported problems
Stryker Corporation · [Universal Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 200 cm Length, Do not use if package is damaged] · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327061215), received between Jun 12, 2018 and Jun 12, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2018Device Operates Differently Than Expected
IT WAS REPORTED THAT THE DEVICE WAS NOT PROPERLY ILLUMINATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7594297 ↗
Other Light, catheter, fiberoptic, glass, ureteral devices
- Bush G16746Cook Incorporated · Light, catheter, fiberoptic, glass, ureteral8 reports
- n.a. 496UKarl Storz GmbH & Co. KG · Light, catheter, fiberoptic, glass, ureteral3 reports
- Bush G16737Cook Incorporated · Light, catheter, fiberoptic, glass, ureteral1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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