Wallace TT1816NRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 15019315015663), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 16, 2026.
Most reported problems
Device problems
- Material Too Rigid or Stiff1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2017Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT A WALLACE¿ TRIAL TRANSFER CATHETER WAS "STIFFER THAN USUAL". A DOCTOR OBSERVED THAT THE CATHETER APPEARED TO CAUSE TRAUMA AND A BLEEDING CONDITION DURING AN IN VITRO FERTILIZATION PROCEDURE. NO PERMANENT INJURY WAS REPORTED.
Patient problems: Blood Loss
MAUDE report 6711923 ↗
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- Sydney IVF G18740Cook Incorporated · CATHETER, ASSISTED REPRODUCTION3 reports
- Soft-Pass G30399Cook Incorporated · CATHETER, ASSISTED REPRODUCTION2 reports
- Soft-Trans G26669Cook Incorporated · CATHETER, ASSISTED REPRODUCTION2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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