Agency classClass IOur severity:Severe FDA (Devices)·Z-1758-2019·Announced 2019-06-26

Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

Cook Inc. is recalling 73 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 with a structural defect (bursting below rated pressure) that poses a risk of significant injury (vessel injury, balloon fragmentation), meeting the criteria for a Severe (4) rating.

Plain-English summary

Cook Inc. is recalling 73 units of the Advance Enforcer 35 Focal Force PTA Balloon Catheter (6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257). The affected units are identified by lot numbers 9338194, 9234423, 9278982, 9209468, 9248603, and 9320429. The product is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries and obstructive lesions of native or synthetic arteriovenous dialysis fistulae, and 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 a delay in the procedure, additional intervention, vessel injury, or 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. Users 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/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in…
Manufacturer: Cook Inc.
Category: Medical Device — Cardiovascular / Vascular
Hazard: structural-defect
vessel-injury
balloon-fragmentation
Affected units: 73

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 (6)

Lot Numbers: 9338194
9234423
9278982
9209468
9248603
9320429

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 3 products in this recall →

Same manufacturer · Cook Inc.

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Same hazard · structural defect