Advance G34374Recalls & reported problems
Cook Incorporated · Advance, 35LP 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002343747), received between Aug 24, 2016 and Aug 24, 2016 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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 Rupture1
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2016Material Separation; Material Separation
IT WAS REPORT THAT DURING AN ANGIOPLASTY THE RADIOLOGIST INFLATED THE BALLOON TO 5 ATM AND THE BALLOON BURST, POSSIBLY CIRCUMFERENTIALLY (MDR # 1820334-2016-00838). WHEN THE RADIOLOGIST TRIED TO REMOVE THE BALLOON CATHETER IT SEEMED STUCK AND THEN A PIECE BROKE OFF THE END, REMAINING INSIDE THE PATIENT. A LARGER SHEATH AND SNARE WERE USED TO CAPTURE THE PIECE OF BALLOON THAT WAS IN THE PATIENT ANATOMY (MDR # 1820334-2016-00820). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE ALLEGED INCIDENT REPORTEDLY PROLONGED THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5900608 ↗InjuryAug 24, 2016Material Rupture; Material Rupture
IT WAS REPORT THAT DURING AN ANGIOPLASTY THE RADIOLOGIST INFLATED THE BALLOON TO 5 ATM AND THE BALLOON BURST, POSSIBLY CIRCUMFERENTIALLY (MDR # 1820334-2016-00838). WHEN THE RADIOLOGIST TRIED TO REMOVE THE BALLOON CATHETER IT SEEMED STUCK AND THEN A PIECE BROKE OFF THE END, REMAINING INSIDE THE PATIENT. A LARGER SHEATH AND SNARE WERE USED TO CAPTURE THE PIECE OF BALLOON THAT WAS IN THE PATIENT ANATOMY (MDR # 1820334-2016-00820). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE ALLEGED INCIDENT REPORTEDLY PROLONGED THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 5900491 ↗
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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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