Advance G26890Recalls & reported problems
Cook Incorporated · ATB Advance, PTA Dilatation Catheter · Class 2
All models of Advance (206)
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 00827002268906), received between Apr 5, 2019 and Apr 5, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionApr 5, 2019Fracture; Fracture
IT WAS INITIALLY REPORTED THAT THE MATERIAL OF AN ATB ADVANCE BALLOON CATHETER WAS BROKEN. FURTHER DETAIL WAS PROVIDED STATING THAT A FRACTURE WAS IDENTIFIED ON THE COMPLAINT DEVICE. THIS WAS OBSERVED BY THE "SECTOR RESPONSIBLE FOR STORING THE PRODUCT," AND WAS NOTICED WHILE THE DEVICE WAS IN ITS PACKAGING. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8487306 ↗
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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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