AVANOS 13537Recalls & reported problems
Avanos Medical, Inc. · ON-Q* Antimicrobial Expansion Kits with SilverSoaker* Antimicrobial Catheter, 1 in./25 mm · Class 2
Data updated Oct 16, 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 00193494135379), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2021Break; Break
PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS INSERTED AND RAN WITHOUT ISSUE. UPON REMOVAL, THE CATHETER APPEARED TO HAVE SNAPPED AND THE DISTAL 5CM OF CATHETER WAS MISSING. PATIENT'S CURRENT STATUS WAS LISTED AS "OK - DISCHARGED HOME." ADDITIONAL INFORMATION RECEIVED 25-MAR-2021 INDICATED A DECISION WAS MADE TO NOT DO ANYTHING ABOUT THE RETAINED PART OF THE CATHETER. A SCAN WAS PERFORMED WHICH DID NOT SUGGEST ANY PROBLEMS RELATED TO THE CATHETER AND THE PATIENT WAS DISCHARGED AS USUAL.
Patient problems: Foreign Body In Patient
MAUDE report 11660892 ↗
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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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