Advance G50314Recalls & reported problems
Cook Incorporated · Advance, 14LP 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
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002503141), received between Mar 28, 2017 and Dec 17, 2020 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (10 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 Rupture10
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2020Material Rupture; Material Rupture
AS REPORTED, DURING ANGIOPLASTY OF A SEVERELY CALCIFIED, 99-100% OCCLUDED LESION WITHIN THE SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON THE FIRST INFLATION. ANOTHER MANUFACTURER¿S 6 FRENCH SHEATH WAS USED AS WELL AS AN UNKNOWN INFLATION DEVICE. THE BALLOON WAS REMOVED BY ITSELF AND ANOTHER MANUFACTURER¿S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11026914 ↗MalfunctionMar 24, 2020Material 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 Consequences Or Impact To Patient
MAUDE report 9871874 ↗MalfunctionMar 18, 2020Material 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 Consequences Or Impact To Patient
MAUDE report 9847744 ↗MalfunctionJan 30, 2020Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9648053 ↗MalfunctionSep 24, 2019Material 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 Consequences Or Impact To Patient
MAUDE report 9109351 ↗MalfunctionJan 2, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE PATIENT WAS REPORTED TO HAVE A SEVERELY CALCIFIED LESION IN THE POPLITEAL ARTERY. WHEN THE BALLOON WAS ADVANCED THROUGH THE FEMORAL ARTERY TO THE LESION, IT RUPTURED. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT HAS NOT BEEN REPORTED THAT ANY SECTION OF THE DEVICE REMAINED IN THE PATIENT OR THAT THE PATIENT REQUIRED ADDITIONAL PROCEDURES AS A RESULT OF THE EVENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IT HAS ALSO BEEN PROVIDED THAT THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8209781 ↗MalfunctionSep 11, 2018Material Rupture; Material Rupture
IT WAS REPORTED, DURING AN UNSPECIFIED ENDOVASCULAR THERAPY (EVT) PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED WHEN IT WAS INFLATED TO NOMINAL PRESSURE IN A SEVERELY CALCIFIED LESION. BRACHIAL APPROACH WAS USED, AND ANOTHER MANUFACTURER'S BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7865491 ↗MalfunctionJun 14, 2018Material Rupture
THE COMPLAINANT REPORTED THAT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED FOR PRE-DILATION IN THE LEFT SFA (SUPERFICIAL FEMORAL ARTERY) BY CROSSOVER APPROACH. THE BALLOON RUPTURED AT THE NOMINAL PRESSURE VALUE. ANOTHER DEVICE WAS USED TO COMPETE THE PROCEDURE, AND THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7601775 ↗MalfunctionMay 10, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED AT APPROXIMATELY 10 ATMOSPHERES (ATM) WHEN THE PHYSICIAN DILATED THE LESION. NO SPECIFIC CALCIFICATION OR TORTUOSITY WAS OBSERVED IN THE PATIENT'S ANATOMY. NO RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN CROSSED THE TARGET LESION. ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7503218 ↗MalfunctionFeb 7, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING A RIGHT LEG ANGIOGRAM, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED AT AN INFLATION PRESSURE OF APPROXIMATELY TWO (2) ATMOSPHERE (ATM). THE BALLOON CATHETER WAS REMOVED, AND ANOTHER DEVICE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT'S LESION WAS LOCATED IN THE DISTAL POPLITEAL ARTERY; NO ANGULATION PRESENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7247180 ↗MalfunctionMar 28, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT THE ADVANCE14 LP LOW PROFILE BALLOON CATHETER WAS INFLATED WITH 8 ATM IN THE PATIENT'S BODY, WHEN IT RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6438842 ↗
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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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