Cook recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm due to balloons bursting below rated pressure, potentially causing vessel injury or procedure delays.
Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
Cook is recalling its Advance Enforcer 35 Focal Force PTA Balloon Catheter because balloons can burst under pressure, risking vessel injury or procedure delays. This affects medical devices used in peripheral artery treatments.
The balloons can burst below the rated pressure during use, which may cause vessel injury, procedure delays, or balloon fragments in the patient. This happens when the device is used in peripheral arteries without sufficient pressure tolerance.
Healthcare providers using the Advance Enforcer 35 Focal Force PTA Balloon Catheter for peripheral artery procedures are most at risk. Patients undergoing these procedures may experience complications if the device is used.
Check for the catalog number ASB5-35-50-6-4 and lot numbers 9234424 or 9331618 on the product packaging. The device is used for peripheral artery procedures, not cerebral or coronary treatments.
Verify the catalog number ASB5-35-50-6-4 and lot numbers 9234424 or 9331618 on the device packaging.
Multiple complaints reported balloons bursting below rated pressure, which could cause vessel injury, procedure delays, or balloon fragments in the patient.
The recall record does not specify a remedy, so check the product details to confirm if it is affected and contact Cook for further instructions.
The device is intended for peripheral artery procedures but may burst under pressure, risking vessel injury or procedure complications.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1756-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-1756-2019 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
