Advance G26906Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002269064), received between Mar 31, 2017 and Mar 31, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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 Rupture1
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.
InjuryMar 31, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING A FISTULAGRAM PROCEDURE, THE ATB ADVANCE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY DURING BALLOON INFLATION. THE PHYSICIAN NOTED THAT A PIECE OF THE BALLOON WAS STILL ATTACHED TO THE WIRE. A COMPETITOR'S SNARE WAS USED TO REMOVE THIS PORTION OF THE BALLOON. IT IS UNKNOWN IF ANY OTHER PORTION OF THE BALLOON REMAINED IN THE PATIENT. THERE WERE NO REPORTED ADVERSE EVENTS OR INJURY TO THE PATIENT AS A RESULT OF THE REPORTED EVENT OR ADDITIONAL INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 6450189 ↗
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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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