Advance Enforcer G35257Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002352572), received between Jan 8, 2019 and Oct 4, 2021 — classified as 8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Material Rupture; Material Rupture

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569518 ↗
• MalfunctionJul 20, 2020Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294830 ↗
• MalfunctionNov 5, 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 9280445 ↗
• MalfunctionAug 14, 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 8892405 ↗
• MalfunctionAug 13, 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 8887730 ↗
• MalfunctionFeb 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 8363488 ↗
• MalfunctionFeb 11, 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 8327876 ↗
• MalfunctionJan 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, AN ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS INFLATED FOR 90 SECONDS AT 10 ATMOSPHERES (ATM) IN A CALCIFIED LESION IN THE MALE PATIENT'S SUPERFICIAL FEMORAL ARTERY. AFTER THE 90 SECONDS, THE BALLOON RUPTURED. THE PERIPHERAL INTERVENTION PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER BALLOON. THE TYPE AND RATIO OF CONTRAST WAS UNKNOWN. THE PATIENT'S VESSEL WAS CALCIFIED BUT ANGULATION WAS NOT KNOWN. DIRECTION OF BALLOON RUPTURE (CIRCUMFERENTIAL OR LONGITUDINAL) WAS ALSO NOT KNOWN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228553 ↗