Advance G34339Recalls & reported problems
Cook Incorporated · Advance, 18LP 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002343396), received between Mar 16, 2020 and Oct 3, 2023 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Difficult to Remove1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
AS REPORTED, DURING AN ANGIOGRAM, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. THE ANATOMY WAS TORTUOUS AND HIGHLY CALCIFIED. THE BALLOON CATHETER WAS ADVANCED THROUGH AN UNSPECIFIED COOK 6-FRENCH, 45-CENTIMETER ANSEL SHEATH. ANOTHER MANUFACTURER'S INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME TO FOURTEEN ATMOSPHERES, WITHIN A 70% OCCLUDED LESION IN THE LEFT COMMON FEMORAL ARTERY, AT WHICH POINT THE BALLOON RUPTURED CIRCUMFERENTIALLY. BLOOD WAS NOTED WITHIN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. UPON ATTEMPTED REMOVAL OF THE BALLOON, IT WRAPPED AROUND THE SHEATH AND THE DEVICES BECAME STUCK IN THE PATIENT'S GROIN. THE PATIENT WAS TAKEN TO SURGERY, AND AN OPEN SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE BALLOON CATHETER AND SHEATH. THE PATIENT IS REPORTEDLY DOING WELL. THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE COOK SHEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17865105 ↗InjuryMar 16, 2020Material Rupture; Material Separation; Material Rupture; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN ATTEMPTED REMOVAL OF THE SEPARATED PORTION OF THE BALLOON AT THE TIME OF THE EVENT. THE REPORTER CONFIRMED THAT THE PATIENT HAD A BLOOD CLOT. THE PATIENT IS REPORTEDLY DOING WELL.
Patient problems: Foreign Body In Patient; No Code Available; Thrombus
MAUDE report 9834960 ↗
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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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