Cook recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm due to balloons bursting below rated pressure, risking vessel injury or procedure delays. Affected units have specific lot numbers.
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 during medical procedures. This may cause vessel injury, procedure delays, or balloon fragments in the patient. Healthcare providers using this specific model should stop using it immediately.
The balloons in this catheter can burst below their rated pressure during medical procedures. This may cause delays in treatment, require additional interventions, or lead to vessel injury or balloon fragments inside the patient.
Healthcare providers using the Advance Enforcer 35 Focal Force PTA Balloon Catheter for peripheral artery procedures are affected. Patients undergoing procedures with this catheter are at risk of vessel injury or balloon fragments.
Check for the catalog number ASB5-35-80-6-4 and lot numbers 9212015, 9243035, 9320430, or 9386804 on the product packaging. This catheter is used for peripheral artery procedures, not for cerebral or coronary vessels.
Immediately stop using the Advance Enforcer 35 Focal Force PTA Balloon Catheter if it has the catalog number ASB5-35-80-6-4 and one of the listed lot numbers.
The balloons can burst below rated pressure during procedures, potentially causing vessel injury, procedure delays, or balloon fragments in the patient.
Lot numbers 9212015, 9243035, 9320430, and 9386804 are affected.
No, the catheter is not safe for use as it can burst during procedures, risking vessel injury or balloon fragments in the patient.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1757-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-1757-2019 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.
