Recall Z-1757-2019— Cook Inc.

Name: FDA recall Z-1757-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-24

Class I · Terminated

Class I FDA medical device recall by Cook Inc., initiated 2019-05-24, terminated 2019-10-31. It names one FDA 510(k) clearance: K141322. Product: Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 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: 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..

Recalling firm: Cook Inc.
Classification: Class I
Status: Terminated
Initiated: 2019-05-24
Terminated: 2019-10-31
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K141322 — ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETERCook Incorporated·cleared 2015-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.