Advance Enforcer G35252Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002352527), received between Jan 26, 2018 and Feb 26, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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.

• MalfunctionFeb 26, 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 8370416 ↗
• MalfunctionJan 31, 2019Material Rupture; Material Rupture

  ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292952 ↗
• MalfunctionDec 17, 2018Material Rupture

  THE COMPLAINANT REPORTED A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) IN A VERY CALCIFIED SFA (SUPERFICIAL FEMORAL ARTERY). IT WAS NOTED THAT THERE WAS "VERY POINTED" PLAQUE IN THE MIDDLE OF THE SFA. THE PHYSICIAN STARTED DIRECTLY WITH THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER. THE BALLOON WAS INFLATED VERY SLOWLY "ATM BY ATM." THE ENFORCER BALLOON BURST AT 6 ATM. THE STENOSIS WAS NOT OPEN, SO THE PHYSICIAN DILATED ANOTHER ENFORCER BALLOON OF THE SAME SIZE VERY SLOWLY AGAIN. HOWEVER, THE SECOND BALLOON BURST AT 16 ATM. AFTER THE ANGIOGRAM, STENOSIS WAS OPEN, SO THERE WERE NO FURTHER ACTIONS. BOTH OF THE COMPLAINT DEVICES WERE NOTED TO BE FROM THE SAME LOT, AND THE PRODUCT PROBLEMS DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8169656 ↗
• MalfunctionDec 17, 2018Burst Container or Vessel

  THE COMPLAINANT REPORTED THAT THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER BURST AT 15 ATM (ATMOSPHERES) DURING A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) OF A HEAVILY CALCIFIED SFA (SUPERFICIAL FEMORAL ARTERY). THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8168839 ↗
• MalfunctionFeb 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING SHUNT DILATATION OF THE PATIENT'S LEFT ARM TO TREAT SUPERFICIAL FEMORAL ARTERY (SFA) LESION, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS UNABLE TO BE INFLATED AS IT WAS LONGITUDINALLY RUPTURED. NO PRESSURE WAS APPLIED TO THE BALLOON DURING THE EVENT. THE PATIENT'S ARTERIES WERE NOTED TO BE ANGULATED. ANOTHER MANUFACTURER'S SEVEN (7) FR SHEATH AND A WIRE GUIDE WERE IN PLACE DURING REMOVAL OF THE DEVICE. UPON BALLOON CATHETER WITHDRAWAL, A CLOCKWISE ROTATION OF THE BALLOON WAS NOT CONDUCTED. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7263852 ↗
• MalfunctionJan 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A SHUNT DILATATION FOR THE PATIENT'S LEFT ARM, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS OBSERVED TO BE LONGITUDINALLY RUPTURED DURING INFLATION. NO PRESSURE WAS APPLIED DURING INFLATION. THE PATIENT'S VESSEL WAS NOTED TO BE ANGULATED. ANOTHER MANUFACTURER'S 7 FR SHEATH, AND A WIRE GUIDE WERE UTILIZED DURING THE EVENT. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7225685 ↗
• MalfunctionJan 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT OF A POPLITEAL ARTERY STENOSIS VIA THE FEMORAL ARTERY, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER LONGITUDINALLY RUPTURED DURING DILATATION. IT WAS NOTED THAT THE PATIENT'S POPLITEAL ARTERY WAS ANGULATED AND CALCIFIED. BLOOD WAS BEING DIRECTLY ASPIRATED; THE BALLOON WAS NOT BEING INFLATED DURING THE EVENT. ANOTHER MANUFACTURER'S 7 FR SHEATH, AND A WIRE GUIDE WERE IN PLACE. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7224429 ↗
• MalfunctionJan 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A FISTULAPLASTY, TWO ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETERS (LOT NUMBER 8316798) RUPTURED AT INFLATION PRESSURES OF 20 AND 22 ATMOSPHERE (ATM). ANOTHER MANUFACTURER'S INFLATION HANDLE WAS USED FOR EACH CATHETER. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7222702 ↗