Advance G52335Recalls & reported problems
Cook Incorporated · Advance, 35LP Low Profile PTA Balloon 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 10827002523354), received between Jul 26, 2017 and Jul 26, 2017 — classified as 1 malfunction.
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
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2017Material Rupture; Material Rupture
IT IS ALLEGED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED DURING A PROCEDURE INVOLVING A SEVERELY CALCIFIED LESION IN THE PATIENT'S LEFT SFA WHEN THE BALLOON RUPTURED. THE BALLOON WAS ADVANCED VIA IPSILATERAL APPROACH FROM THE PATIENT'S LEFT CFA FOLLOWING A WIRE GUIDE. IT WAS DURING THE DILATION THAT THE BALLOON RUPTURED AT 10 ATM OF PRESSURE, WHICH LIES WITHIN THE NOMINAL, OR RECOMMENDED, PRESSURE PROVIDED IN THE IFU. THERE WAS NO UNINTENDED SECTION OF THE DEVICE REMAINING INSIDE OF THE PATIENT. IT WAS UNKNOWN AS TO WHAT DIRECTION THE BALLOON RUPTURED. THE DEVICE WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED BY THE CUSTOMER. IT IS NOT KNOWN WHAT TYPE OF CONTRAST OR MIX OF CONTRAST TO SALINE WAS USED TO INFLATE THE BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ANOTHER MANUFACTURER'S DEVICE. NO ADVERSE EVENT HAVE BEEN REPORTED REGARDING THIS INSTANCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6745551 ↗
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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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