Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters
Cook Inc. is recalling 131 Advance Enforcer 35 Focal Force PTA Balloon Catheters because multiple complaints reported the balloons bursting below their rated pressure.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Cook Inc. is recalling 131 units of the Advance Enforcer 35 Focal Force PTA Balloon Catheter (6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252). The recall involves specific lot numbers: 9212015, 9243035, 9320430, and 9386804. The affected products were distributed worldwide, including in the United States (Florida, Ohio, and Washington) and in Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and the United Kingdom.
The recall was initiated after multiple complaints were received regarding balloons bursting below the rated burst pressure. The FDA has classified this as a Class I recall. Potential adverse events associated with the use of these affected products include a delay in the procedure, the need for additional intervention, vessel injury, and balloon fragmentation within the patient.
The Advance Enforcer 35 Focal Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral arteries, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is not for use in the cerebral or coronary vasculature. Healthcare facilities and distributors should stop using the affected products and contact Cook Inc. for further instructions.
The recalled product
- Product
- Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in periphe
- Manufacturer
- Cook Inc.
- Affected units
- 131
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: 9212015
- 9243035
- 9320430
- 9386804
Distribution
Part of a larger recall action
This product is one of 3 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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