Recall Z-1758-2019 ยท PNO Catheter, Percutaneous, Cutting/Scoring
Cook Inc.
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 peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions
| Date | Jun 17, 2019 (initiated May 24, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 5/24/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. Actions to be Taken by the Customer 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Please complete |
| Quantity | 73 |
| Distribution | 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, Unite |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141322 | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER Cook Incorporated, Mar 27, 2015 |