Advance G50335Recalls & 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
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002503356), received between Aug 11, 2016 and Jun 6, 2022 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (12 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 Rupture12
- Fluid/Blood Leak1
- Torn Material1
Patient problems
- No Known Impact Or Consequence To Patient10
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2022Material Rupture; Material Rupture
AS REPORTED, DURING ANGIOPLASTY OF A SEVERELY CALCIFIED 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 AND THE BALLOON WAS INFLATED WITH AN UNKNOWN INFLATION DEVICE. THE INFLATION PRESSURE IS UNKNOWN. THE BALLOON WAS REMOVED BY ITSELF AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14603885 ↗MalfunctionAug 18, 2021Material 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12337386 ↗MalfunctionJan 12, 2021Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11153786 ↗MalfunctionJun 14, 2018Material Rupture
THE COMPLAINANT REPORTED THAT DURING AN "EVT" PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED TO DILATE THE SEVERELY CALCIFIED STENOSED LESION IN THE LEFT SFA (SUPERFICIAL FEMORAL ARTERY) BY CROSS-OVER APPROACH FROM THE RIGHT CFA (COMMON FEMORAL ARTERY). THE BALLOON RUPTURED LONGITUDINALLY, AT APPROXIMATELY 6ATM (ATMOSPHERES), BEFORE REACHING THE NOMINAL PRESSURE VALUE. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS, 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 7600981 ↗MalfunctionJun 13, 2018Material Rupture
IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE LOW PROFILE BALLOON CATHETER WAS USED, THE BALLOON RUPTURED. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7598028 ↗MalfunctionJun 13, 2018Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE LOW PROFILE BALLOON CATHETER TRAINING SESSIONS, THERE WAS WATER LEAKAGE FROM THE COILED-WIRE SHAFT. THERE WAS NO PATIENT CONTACT DURING THE TRAINING SESSIONS.
Patient problems: No Information
MAUDE report 7597929 ↗MalfunctionJun 13, 2018Material Rupture
THE COMPLAINANT REPORTED THAT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED FROM THE RIGHT CFA (COMMON FEMORAL ARTERY) BY CROSSOVER APPROACH DURING AN "EVT" PROCEDURE. HOWEVER, THE BALLOON RUPTURED WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE DEVICE OVER NOMINAL PRESSURE TO DILATE THE STENOSED LESION OF THE LEFT SFA (SUPERFICIAL FEMORAL ARTERY). ANOTHER BALLOON CATHETER WAS USED TO COMPLETE 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 7596861 ↗MalfunctionJun 12, 2018Material Rupture
IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN LOW PROFILE BALLOON CATHETER WAS USED, THE BALLOON RUPTURED. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7593144 ↗MalfunctionMay 17, 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 Known Impact Or Consequence To Patient
MAUDE report 7522257 ↗MalfunctionMar 1, 2018Material Rupture; Material Rupture
IT WAS REPORTED DURING ENDOVASCULAR TREATMENT (EVT) OF A SEVERELY CALCIFIED BELOW THE KNEE (BK) LESION, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED FROM THE FEMORAL ARTERY AND RUPTURED AT AN INFLATION PRESSURE OF 16 ATMOSPHERE (ATM). ANOTHER MANUFACTURER'S CONTRAST (5:5 CONTRAST TO SALINE RATIO) WAS USED DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 7305812 ↗MalfunctionAug 10, 2017Material Rupture; Material Rupture
AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN UNSPECIFIED PROCEDURE. TREATMENT OF THE RIGHT POPLITEAL ARTERY WAS CONDUCTED BY RIGHT GROIN APPROACH. SLIGHT CALCIFICATION WAS OBSERVED IN THE TARGET LESION. THE CATHETER WAS ADVANCED TO THE LESION THROUGH ANOTHER MANUFACTURER'S 5 FR. SHEATH AND WIRE GUIDE. AFTER THE COMPLAINT DEVICE PASSED THROUGH THE LESION, DILATION WAS BEGAN. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON UP TO 16ATM (RBP). HOWEVER, BEFORE THE AIR PRESSURE REACHED 16ATM, THE BALLOON GOT RUPTURED LONGITUDINALLY. THE EXACT PRESSURE WHEN IT RUPTURED WAS UNKNOWN, BUT PRESUMABLY 12ATM OR 13ATM. IT WAS REPLACED WITH ANOTHER PTA BALLOON IN ANOTHER SIZE (4MM*2CM, LOT#: UNKNOWN) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6785726 ↗MalfunctionMar 21, 2017Material Rupture; Material Rupture
IT WAS REPORTED DURING AN UNSPECIFIED PROCEDURE THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. THERE WAS SEVERE CALCIFICATION IN THE LESION. THE DEVICE WAS ADVANCED OVER ANOTHER MANUFACTURER'S 0.014 INCH WIRE GUIDE FROM THE LEFT GROIN TO THE LEFT SFA IPSILATERALLY. WHILE INFLATING THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THE DIRECTION OF THE RUPTURE OF THE BALLOON IS UNKNOWN. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6420847 ↗MalfunctionDec 19, 2016Material Rupture; Material Rupture
IT WAS REPORTED ACCESS WAS GAINED FROM LEFT RADIAL ARTERY TO THE LESION OF RIGHT EXTERNAL ILIAC ARTERY (EIA). REPORTEDLY THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY OR CALCIFICATION OF COMMON ILIAC ARTERY (CIA). THE PATIENT'S ANATOMICAL FORM WAS REPORTED TO BE SUITABLE FOR THE PROCEDURE. THE DEVICE WAS ADVANCED INTO THE OCCLUDED STENT OVER THE PLACED WIRE GUIDE (ANOTHER MANUFACTURES' WIRE GUIDE, 0.014INCH), AND INFLATED, HOWEVER, IT RUPTURED BEFORE IT REACHED NOMINAL PRESSURE. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. 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 6185808 ↗MalfunctionAug 11, 2016Torn Material; Torn Material
DURING A TIBIAL ANGIOPLASTY PROCEDURE, THE WIRE GOT STUCK DUE TO THE AORTIC ARCH AND IT RIPPED THE EXCHANGE PORT OF THE DELIVERY CATHETER. A NEW ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5868147 ↗
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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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