Advance G30970Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002309705), received between Nov 28, 2018 and Apr 29, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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.
Most reported problems
Device problems
- Material Puncture/Hole2
- Material Rupture2
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2022Material Rupture; Material Rupture
AS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE TARGET LOCATION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TWICE BEFORE RUPTURING ON THE SECOND INFLATION TO NOMINAL PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THERE WAS NO DELAY IN TREATMENT. IT WAS INITIALLY REPORTED THAT NO STENT WAS USED DURING THE PROCEDURE, BUT INFORMATION WAS LATER RECEIVED THAT THE BALLOON WAS INFLATED INSIDE OF A STENT PRIOR TO THE RUPTURE. CLARIFICATION HAS BEEN REQUESTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14254858 ↗MalfunctionOct 29, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10755560 ↗MalfunctionOct 29, 2020Material Puncture/Hole; Material Puncture/Hole
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10755369 ↗MalfunctionNov 28, 2018Material Rupture; Material Rupture
PLEASE SEE H10 FOR ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8110003 ↗
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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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