Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G352

FDA device recall Z-1757-2019 · posted 2019-06-17 · Terminated

Recall details

Recalling firm

Cook Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

PNO

Quantity affected

131

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, Fin

Date initiated

2019-05-24

Date posted

2019-06-17

Date terminated

2019-10-31

Location

Bloomington, IN

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