Intro Tip G09764Recalls & reported problems
Cook Incorporated · Intro-Tip Pneumothorax Set · Class 2
- 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 00827002097643), received between Jun 18, 2019 and Jun 18, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Nonstandard Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Nonstandard Device1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2019Nonstandard Device; Nonstandard Device
Other CATHETER AND TIP, SUCTION devices
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- Wayne G56537Cook Incorporated · CATHETER AND TIP, SUCTION2 recalls33 reports
- Bard® Suction Connector EN0066000C. R. Bard, Inc. · CATHETER AND TIP, SUCTION1 recall6 reports
- Argyle 10142Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12191Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Medline Industries, Inc. OR929KMedline Industries, Inc. · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 12102Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
- Argyle 10102Cardinal Health 200, LLC · CATHETER AND TIP, SUCTION1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.