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# Cook Recalls Advance Enforcer Balloon Catheter
- URL: https://www.fdaweb.com/cook-recalls-advance-enforcer-balloon-catheter/
- Published: 2019-06-18T12:00:00.000Z
- Updated: 2026-09-15T01:33:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144358

Cook Medical has recalled its Advance Enforcer 35 Focal-Force PTA Balloon Catheter (6mm x 4cm) after multiple complaints were received about balloons bursting below the rated burst pressure. The company says that while there have been no reports of malfunctions, deaths, or injury reported for the balloon issue, there is a high occurrence rate. “Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, balloon fragmentation in the patient, and death,” Cook says. The device is used for opening blocked or narrowed arteries that supply blood to the leg (percutaneous transluminal angioplasty).