The Food and Drug Administration (FDA) has identified Cook Medical's Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm as a Class I recall, the most serious type of recall because they can cause serious injuries or death. FDA says multiple complaints were received for balloons bursting below the rated burst pressure. While there were no reports of malfunctions, deaths, or injury reported for this balloon issue, there is a high occurrence rate. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, balloon fragmentation in the patient, and death; 33 devices were recalled in the U.S.
The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is used by healthcare providers for opening blocked or narrowed arteries that supply blood to the leg (percutaneous transluminal angioplasty (PTA)). This catheter is not for use in the brain or heart.
On May 24, 2019, Cook Medical sent an Urgent Medical Device Recall notification letter to customers asking them to:
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.
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.
Please complete the Acknowledgement and Receipt Form within 5 business days. 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 [email protected]. If you have a product to return, contact Stericycle at phone number 855-205-2627 to obtain a credit and reference event number 10082.
Share the notification letter with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred.
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 a.m. and 5:00 p.m. (Eastern Time) or by email to [email protected].
Model Numbers: 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257
Lot Numbers: 9234424, 9331618, 9212015, 9243035, 9320430, 9386804, 9338194, 9234423, 9278982, 9209468, 9248603, 9320429
Manufacturing Dates: October 3, 2018 to December 17, 2018.
Distribution Dates: October 29, 2018 to March 21, 2019.
