Cook Inc. recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter 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 Inc. is recalling its Advance Enforcer 35 Focal Force PTA Balloon Catheter because balloons can burst below the rated pressure during use. This may cause delays in medical procedures, additional interventions, or vessel injuries to patients.
The balloons in the catheter can burst under pressure lower than the rated burst pressure. This may lead to delays in medical procedures, additional interventions, or vessel injuries during treatment.
Healthcare professionals using this catheter for peripheral artery procedures are most at risk. Patients undergoing PTA treatments with the affected product could experience complications.
Check the product's catalog number ASB5-35-135-6-4 and lot numbers: 9338194, 9234423, 9278982, 9209468, 9248603, 9320429. The catheter is used for peripheral artery procedures, not for cerebral or coronary vessels.
Identify the product's catalog number and lot numbers to confirm if it is affected.
The balloons can burst below the rated burst pressure, potentially causing delays in procedures, additional interventions, or vessel injuries.
Lot numbers 9338194, 9234423, 9278982, 9209468, 9248603, 9320429.
No, this catheter is intended for peripheral artery procedures and not for use in cerebral or coronary vasculature.
We’ve drafted a message you can send Cook Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-1758-2019 — Cook Inc. Cook Inc. Hello, I own a Cook Inc. that is covered by recall Z-1758-2019 from Cook Inc.. 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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