IRIS 0220180518Recalls & reported problems
Stryker Corporation · [Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 370 cm Length, Do not use if package is damaged] · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker IRIS ureteral kit is a fiberoptic light source used to illuminate stents and catheters during urologic procedures. The 44 reports mostly describe parts breaking off during a procedure, sometimes inside the patient, plus poor or failing illumination, connector difficulty, and contamination or debris found in the sterile packaging. Eight reports involve injuries and no deaths are described. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07613327174816), received between Aug 28, 2018 and Dec 23, 2025 — classified as 8 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (10 reports).
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
- Packaging Problem10
- Adverse Event Without Identified Device or Use Problem8
- Device Contamination with Chemical or Other Material6
- Output Problem6
- Contamination /Decontamination Problem5
- Contamination4
- Device Unsafe to Use in Environment4
- Insufficient Device Problem Information4
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information21
- No Known Impact Or Consequence To Patient7
- Renal Failure3
- Genital Bleeding2
- Hemorrhage/Blood Loss/Bleeding2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blood Loss1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE IRIS U KIT EXPERIENCED POOR ILLUMINATION DURING CASE. INITIALLY WAS FINE BUT AFTER FEW MINUTES THE IRIS ILLUMINATION TURNED POOR. DIFFICULTY IN CONNECTING 1 BRANCH OF IRIS CONNECTOR TO L10 LED LIGHT SOURCE CONNECTOR. NO IRIS ILLUMINATION OBSERVED IN 1 BRANCH OF IRIS U KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882828 ↗MalfunctionSep 11, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT WHILE IN USE, PRODUCT BROKE OFF IN THE PATIENT. STAFF WAS ABLE TO RETRIEVE THE PIECE THAT BROKE OFF INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23033708 ↗MalfunctionFeb 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717280 ↗MalfunctionDec 22, 2023Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18387523 ↗MalfunctionApr 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16761973 ↗InjuryFeb 15, 2023Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem
IT WAS REPORTED THAT ADDITIONAL PROCEDURE WAS PERFORMED ON THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16383063 ↗MalfunctionNov 9, 2022Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED IN A PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15762938 ↗MalfunctionOct 20, 2022Contamination; Device Unsafe to Use in Environment; Device Unsafe to Use in Environment
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15638550 ↗MalfunctionOct 20, 2022Contamination; Device Unsafe to Use in Environment; Device Unsafe to Use in Environment
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15638545 ↗MalfunctionOct 20, 2022Contamination; Device Unsafe to Use in Environment; Device Unsafe to Use in Environment
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15638538 ↗MalfunctionOct 20, 2022Contamination; Device Unsafe to Use in Environment; Device Unsafe to Use in Environment
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15638534 ↗MalfunctionAug 11, 2022Contamination /Decontamination Problem; Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15209590 ↗MalfunctionAug 11, 2022Contamination /Decontamination Problem; Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15208854 ↗MalfunctionAug 11, 2022Contamination /Decontamination Problem; Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15208841 ↗MalfunctionAug 8, 2022Contamination /Decontamination Problem; Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15188611 ↗MalfunctionAug 8, 2022Contamination /Decontamination Problem; Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15188560 ↗MalfunctionJun 30, 2022Defective Device; Output Problem; Defective Device
IT WAS REPORTED THAT THE STENTS DID NOT LIGHT UP.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14877587 ↗MalfunctionJun 30, 2022Output Problem; Activation Problem; Activation Problem
IT WAS REPORTED THAT THE STENTS DID NOT LIGHT UP.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14877487 ↗MalfunctionJun 22, 2022Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14780695 ↗MalfunctionJun 8, 2022Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14638796 ↗MalfunctionJun 8, 2022Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14634633 ↗MalfunctionJun 8, 2022Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14634599 ↗MalfunctionJun 8, 2022Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14634541 ↗MalfunctionMay 9, 2022Difficult to Advance; Optical Problem; Difficult to Advance
IT WAS REPORTED THAT THE STENTS DID NOT FULLY LIGHT UP.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14337555 ↗MalfunctionApr 18, 2022Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIALS INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137329 ↗
Other Light source, fiberoptic, routine devices
- Integra® 00MLXIntegra Lifesciences (Ireland) Limited · Light source, fiberoptic, routine189 reports
- L9000 0220210000Stryker Corporation · Light source, fiberoptic, routine99 reports
- SafeLight 0233050100Stryker Corporation · Light source, fiberoptic, routine1 recall22 reports
- SafeLight 0233050087Stryker Corporation · Light source, fiberoptic, routine59 reports
- SafeLight 0233050200Stryker Corporation · Light source, fiberoptic, routine1 recall3 reports
- n.a. 495NDKarl Storz GmbH & Co. KG · Light source, fiberoptic, routine23 reports
- PRECISION 0220220000Stryker Corporation · Light source, fiberoptic, routine22 reports
- n.a. 495NCSCKarl Storz GmbH & Co. KG · Light source, fiberoptic, routine19 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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