Z-1756-2019 Class I Terminated
FDA device recall Z-1756-2019 was initiated by Cook Inc. on May 24, 2019 and is designated Class I. Reason for recall: 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, additi… The recall status is terminated (terminated October 31, 2019). Affected quantity: 34.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- May 24, 2019
- Termination Date
- October 31, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34
Product Description
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 peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide The affected product was distributed to the following states: FL, OH, WA. The products were distributed to the following foreign countries: Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Code Information
Lot Numbers: 9234424, 9331618