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  Class 1 Device Recall ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER see related information
Date Initiated by Firm May 24, 2019
Date Posted June 17, 2019
Recall Status1 Terminated 3 on October 31, 2019
Recall Number Z-1756-2019
Recall Event ID 82888
510(K)Number K141322  
Product Classification Catheter, percutaneous, cutting/scoring - Product Code PNO
Product 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.

Code Information Lot Numbers: 9234424, 9331618
Recalling Firm/
Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
Manufacturer 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.
FDA Determined
Cause 2
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 the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or by email to FieldActionsNA@CookMedical.com. 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com. For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in Commerce 34
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, United Arab Emirates, United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PNO and Original Applicant = COOK INCORPORATED