Advance G52266Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002522661), received between Apr 26, 2017 and Oct 7, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 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 9161522 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A FEMALE PATIENT IN HER "EARLY (B)(6) " WITH A NON-HEALING, LEFT FOOT, VASCULAR ULCER, UNDERWENT A STENT PLACEMENT (SITE NOT SPECIFIED) ON (B)(6) 2018 IN AN OUTPATIENT FACILITY. MULTIPLE COOK PRODUCTS WERE USED. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A FEVER (TEMPERATURE UNKNOWN TO COMPLAINANT) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH SEPSIS WHICH WAS TREATED WITH "FLUIDS AND IV ANTIBIOTICS" AND IS "DOING FINE". REPORTEDLY, LAB RESULTS INDICATE A STRAIN OF STREP WAS IDENTIFIED, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. PER THE COMPLAINANT: "SEVERAL COOK PRODUCTS WERE INVOLVED WITH ORIGINAL PROCEDURE, UNKNOWN AND NOT ALLEGED AT THIS TIME IF ANY OF THEM MAY HAVE CONTRIBUTED TO THIS." ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND RELEVANT MEDICAL HISTORY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. PLEASE REFERENCE ADDITIONAL MEDWATCH NUMBERS REGARDING ALL COOK PRODUCTS IN USE DURING THE PROCEDURE: CID-20-30-NG (1820334-2018-01470) ; KCFW-5.0-38-RB (1820334-2018-01613); KCFW-6.0-18/38-45-RB-ANL0-HC (1820334-2018-01614); MPIS-402-NT-U-SST (1820334-2018-01615); PTA5-35-135-6-6.0 (

  Patient problems: Sepsis

  MAUDE report 7634265 ↗
• MalfunctionAug 10, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON WAS PUT UP DURING ANGIOPLASTY, AND INFLATED TO 8 FOR THE SECOND TIME, WHEN THE BALLOON BROKE /SEPARATED IN HALF. ALLEGEDLY, THE PHYSICIAN TRIED TO REMOVE THE BALLOON THROUGH THE SHEATH, AND DOING SO, THE BALLOON "ACCORDIONED." THE SHEATH AND BALLOON HAD TO BE REMOVED TOGETHER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DM STATED AFTER THE DEVICES WERE REMOVED, SHE TRIED TO REMOVE THE BALLOON FROM THE SHEATH BUT COULD NOT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6785607 ↗
• MalfunctionApr 26, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ILIAC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING AN ADVANCE 35 LOW PROFILE BALLOON CATHETER, UPON INFLATION, THE BALLOON RUPTURED AT 3ATM. AT THE TIME OF THIS REPORT, IT IS UNKNOWN WHICH DIRECTION THE BALLOON BURST. THE TYPE OF CONTRAST THAT WAS USED WAS UNKNOWN. THE MIXTURE OF CONTRAST TO SALINE WAS SAID TO BE 50/50. THE LESION WAS LOCATED IN THE RIGHT COMMON ILIAC. THE VESSEL WAS DESCRIBED TO HAVE A SMALL AMOUNT OF ANGULATION AND CALCIFICATION. NO PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6522630 ↗