Recall Z-0588-2016— Boston Scientific Corporation

Name: FDA recall Z-0588-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2015-11-25, terminated 2016-04-08. It names one FDA 510(k) clearance: K132914. Product: Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .. Reason: Potential for separation of the proximal handle from the shaft..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Terminated: 2016-04-08
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K132914 — ACUITY PRO LEAD DELIVERY SYSTEMBoston Scientific·cleared 2014-04-03

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

Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .

Reason for recall

Potential for separation of the proximal handle from the shaft.

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