ICU Medical 42052-01Recalls & reported problems
Icu Medical, Inc. · 10 cc Contamination Sheath Syringe · 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 00887709042759), received between May 14, 2021 and May 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2021Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT THERE WAS PATIENT INVOLVEMENT AND THAT THE BROKEN TUBING WAS NOTICED DURING INFUSION. THERE WAS NO LEAKING; HOWEVER IT WAS IDENTIFIED THAT AIR WAS BEING PULLED INTO SETUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824543 ↗
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.
Other Catheter, intravascular, diagnostic devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page