ICU Medical 46098-75Recalls & reported problems
Icu Medical, Inc. · CATH LAB KIT W/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4 · 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 00887709049628), received between Oct 3, 2017 and Oct 3, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
1 other recall cover devices cleared under the same FDA submission (K932141); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
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.
MalfunctionOct 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
VOLUNTARY EVENT REPORT MW 5070799 RECEIVED REPORTING PARTICULATE ISSUE(S) WITH USE OF ONE 46098-75 CATH LAB KIT. THE MW 5070799 REPORT DESCRIBES THE (B)(6) 2017 EVENT AS FOLLOWS ".. DURING A PROCEDURE, THE PHYSICIAN NOTED A SMALL PIECE OF PLASTIC IN THE FLUID AFTER HE HAD PULLED BACK ON THE SYRINGE WHICH WAS ATTACHED TO THE MANIFOLD. ORIGIN OF THE PLASTIC IS UNK BUT MAY HAVE ORIGINATED IN THE MANIFOLD. SYRINGE APPEARS INTACT." ALTHOUGH ADDITIONAL EVENT INFORMATION AND DEVICE RETURN STATUS WERE REQUESTED FACILITY HAD NO ADDITIONAL EVENT INFORMATION OR THE LOCATION / STATUS OF THE INVOLVED DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6909395 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K932141. One submission often covers many models, so check the product and lot details in each record.
- Z-0621-05 · Nov 2, 2004 · TerminatedCatheterization Kits containing Angiographic Syringes with rotator connector.
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- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H749085263001Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 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 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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