Advance EnforcerRecalls & reported problems across all models
Cook Incorporated · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of Advance Enforcer by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2017 and Oct 4, 2021 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Advance Enforcer problems
Device problems
- Material Rupture20
- Burst Container or Vessel1
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient9
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Advance Enforcer models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Advance Enforcer G35252Catheter, percutaneous, cutting/scoring8 reports
- Advance Enforcer G35257Catheter, percutaneous, cutting/scoring8 reports
- Advance Enforcer G35253Catheter, percutaneous, cutting/scoring2 reports
- Advance Enforcer G35261Catheter, percutaneous, cutting/scoring2 reports
- Advance Enforcer G35250Catheter, percutaneous, cutting/scoring1 report
- Advance Enforcer G35254Catheter, percutaneous, cutting/scoring1 report
Recent Advance Enforcer adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 8, 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 Known Impact Or Consequence To Patient
MAUDE report 8404235 ↗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 ↗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 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 ↗MalfunctionJan 22, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE OF A DIALYSIS ACCESS CIRCUIT, AN ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER RUPTURED. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF TYPE 1 DIABETES, DIABETIC NEUROPATHY, AND A HISTORY OF PREVIOUS INTERVENTIONS OF THE ACCESS CIRCUIT. THE PATIENT PRESENTED WITH A 70% RESTENOSIS OF A LEFT BRACHIOCEPHALIC FISTULA. THE TARGET VENOUS OUTFLOW LESION WAS LOCATED 1 CM DISTAL TO THE ARTERIO-VENOUS (AV) ANASTOMOSIS OR GRAFT-VEIN ANASTOMOSIS UP TO THE CONFLUENCE OF THE CEPHALIC AND AXILLARY VEINS. THE REFERENCE VESSEL DIAMETER (RVD) WAS 7MM AND THE LESION LENGTH WAS 2MM. THE COMPLAINT DEVICE WAS INFLATED TO 12 ATMOSPHERES WITH A 1:2 RATIO OF CONTRAST (OPTIRAY) TO HEPARINIZED SALINE WHEN THE BALLOON RUPTURED LONGITUDINALLY. ANOTHER MANUFACTURER'S BALLOON WAS THEN USED, WHICH ALSO RUPTURED. ANOTHER MANUFACTURER'S HIGH PRESSURE BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8266667 ↗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 ↗MalfunctionDec 17, 2018Material Rupture
THE COMPLAINANT REPORTED THAT THE DOCTOR HAD USED ANOTHER MANUFACTURER'S DEVICE AND PERFORMED THROMBOLYSIS. THERE WAS PERSISTENT INTRASTENT THROMBUS, SO THE DOCTOR NEEDED TO BALLOON THROUGH THAT. THE BALLOON ON THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER RUPTURED WHILE BALLOONING A SERIES OF STENTS. IT DID "WELL" AT BALLOONING THE TOP AND MIDDLE STENTS, BUT RUPTURED ON THE INFERIOR ASPECT OF THE WALL STENT. THE ENFORCER BURST LONGITUDINALLY AT A RATE OF APPROXIMATELY 6ATM (ATMOSPHERES). ANOTHER MANUFACTURER'S BALLOON WAS USED TO BALLOON THE DISTAL STENT, AND IT DID NOT RUPTURE. THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8169684 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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