Advance G34329Recalls & 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 10827002343297), received between Jul 27, 2017 and Aug 15, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 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 Rupture4
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 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 8898357 ↗MalfunctionAug 23, 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 7810330 ↗MalfunctionJul 27, 2017Material Rupture; Material Rupture
IT IS ALLEGED THAT AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS BEING USED FOR AN ANGIOGRAM WITH A LESION IN THE LEFT COMMON FEMORAL WHEN THE BALLOON RUPTURED. IT WAS REPORTED THAT BALLOON WAS INFLATED WITH 6 ATM AT THE TIME OF RUPTURE, USING A 50/50 MIXTURE OF SALINE AND CONTRAST. THE DIRECTION OF BURST IS UNKNOWN, AND VESSEL CALCIFICATION WAS NOTED. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6746884 ↗MalfunctionJul 27, 2017Material Rupture; Material Rupture
IT IS ALLEGED THAT AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS BEING USED FOR AN ANGIOGRAM WITH A LESION IN THE LEFT COMMON FEMORAL WHEN THE BALLOON RUPTURED. IT WAS REPORTED THAT BALLOON WAS INFLATED WITH 12 ATM AT THE TIME OF RUPTURE, USING A 50/50 MIXTURE OF SALINE AND CONTRAST. THE DIRECTION OF BURST IS UNKNOWN, AND VESSEL CALCIFICATION WAS NOTED. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6746878 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page