Advance G26900Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002269002), received between Jun 11, 2018 and Oct 20, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
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 Rupture2
- Hole In Material1
- Inflation Problem1
Patient problems
- Calcium Deposits/Calcification1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2018Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 7988156 ↗MalfunctionJun 11, 2018Hole In Material; Inflation Problem; Material Rupture
THE ATB ADVANCE BALLOON CATHETER WAS USED FOR THE "EVT". THE PHYSICIAN ADVANCED THE COMPLAINT BALLOON OVER THE WIRE GUIDE, BUT THE BALLOON WOULD NOT INFLATE MORE THAN 6 ATM (ATMOSPHERES). THE PHYSICIAN CONFIRMED THE PINHOLE AT THE BALLOON BY THE ANGIOGRAPHY AND SUGGESTED THAT THE BALLOON RUPTURE WAS DUE TO CALCIFICATION IN THE LESION. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME KIND, AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: Calcium Deposits/Calcification
MAUDE report 7589468 ↗
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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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