Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters
Cook Inc. is recalling 34 Advance Enforcer 35 Focal Force PTA Balloon Catheters because they may burst below the rated pressure, posing risks of vessel injury and balloon fragmentation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect that can cause significant injury, specifically vessel injury and balloon fragmentation, which aligns with the rubric criteria for a Severe (4) rating.
Plain-English summary
Cook Inc. is recalling 34 units of the Advance Enforcer 35 Focal Force PTA Balloon Catheter (6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248). The affected units are from Lot Numbers 9234424 and 9331618. This medical device is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries and obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It is not for use in the cerebral or coronary vasculature.
The recall was initiated after multiple complaints were received regarding balloons bursting below the rated burst pressure. The use of affected products may result in adverse events, including a delay in the procedure, the need for additional intervention, vessel injury, and balloon fragmentation in the patient.
The affected products were distributed worldwide, including in the United States (Florida, Ohio, and Washington) and in Belgium, Denmark, Finland, Germany, Italy, the Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, the United Arab Emirates, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact Cook Inc. for further instructions.
The recalled product
- Product
- Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in…
- Manufacturer
- Cook Inc.
- Affected units
- 34
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 (2)
- Lot Numbers: 9234424
- 9331618
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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