Advance G50319Recalls & 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
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002503196), received between May 29, 2018 and Dec 12, 2023 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (8 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 Rupture8
- Fluid/Blood Leak2
- Difficult to Remove1
- Hole In Material1
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2023Material Rupture; Material Rupture
AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ANTEGRADE APPROACH FROM THE RIGHT FEMORAL ARTERY FOR A LESION BELOW THE KNEE WAS OBTAINED WITH ANOTHER MANUFACTURER'S WIRE GUIDE. THE BALLOON CATHETER WAS ADVANCED THROUGH THE CALCIFIED VESSEL AND INFLATED WITHIN NOMINAL PRESSURE AND SUBSEQUENTLY RUPTURED. THE BALLOON CATHETER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME TYPE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18312007 ↗MalfunctionMay 12, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
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 16919496 ↗MalfunctionFeb 2, 2023Material 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 16287671 ↗MalfunctionFeb 3, 2021Difficult to Remove; Difficult to Remove
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11273140 ↗MalfunctionJan 23, 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 9623632 ↗MalfunctionNov 8, 2019Material Rupture; Material Rupture
ADDITIONAL INFORMATION RECEIVED 07NOV2019. AS REPORTED, THE DEVICE WAS USED THROUGH ANOTHER MANUFACTURER'S SHEATH. THE BALLOON RUPTURED AT THE SECOND INFLATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9296654 ↗MalfunctionAug 8, 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 8874081 ↗MalfunctionApr 22, 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 8536927 ↗MalfunctionOct 5, 2018Material Perforation; Material Perforation
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 7938402 ↗MalfunctionJun 14, 2018Material Rupture
THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED TO THE CTO (CHRONIC TOTAL OCCLUSION) LESION OF THE "ATA" CONTRALATERALLY, BUT THE DEVICE WOULD NOT PASS THROUGH THE LESION. THERE WAS THEN AN ATTEMPT TO BALLOON THE DEVICE AT THE PROXIMAL SIDE OF THE CTO LESION, BUT THE BALLOON RUPTURED. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE 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 7602290 ↗MalfunctionJun 13, 2018Material Rupture
IT WAS REPORTED THAT DURING THE BALLOON ANGIOPLASTY 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 7598107 ↗MalfunctionMay 29, 2018Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material
IT WAS REPORTED THAT DURING AN ENDOVASCULAR THERAPY PROCEDURE OF A SUPERFICIAL FEMORAL ARTERY (SFA), THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WOULD NOT PASS THROUGH THE LESION. IPSELATERAL, ANTEGRADE APPROACH WAS GAINED FROM THE LEFT COMMON FEMORAL ARTERY (CFA). AFTER TREATING THE SFA, ANOTHER MANUFACTURER'S WIRE GUIDE WAS ADVANCED PAST THE CALCIFIED LESION. THE COMPLAINT DEVICE WAS ADVANCED OVER THE WIRE GUIDE; HOWEVER, IT COULD NOT PASS THROUGH THE LESION. THEREFORE, AN ADVANCE 14LP (COOK MEDICAL) WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPON REVIEW OF THE RETURNED COMPLAINT DEVICE, A LEAK/HOLE WAS OBSERVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7550394 ↗
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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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