—#142058

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 .

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K132914
Affected lot / code info: Model 8104, Lots: 18279548, 18279734, 18324877, 18329863, 18330946, 18348755, 18351569, 18353214, 18426640, 18461104, 18461521. Model 8105, Lots: 18281110, 18315176, 18322343, 18323156, 18323651, 18324468, 18327210, 18327359, 18345738, 18346540, 18346668, 18347522, 18352159, 18354329, 18379847, 18380498, 18393785, 18394034, 18395315, 18408497, 18408902, 18410018, 18428314, 18435809, 18437015, 18437680, 18439474, 18440388, 18444811, 18445630, 18446236, 18462103, 18462459, 18463154, 18466449, 18478544. Model 8106, Lots: 18286550, 18410783. Model 8107, Lots: 18285401, 18285605, 18312411, 18312981, 18313754, 18337534, 18338037, 18354248, 18411116, 18413022, 18413155, 18413834. Model 8108, Lots: 18273724, 18284294, 18338159, 18414856. Model 8109, Lots: 18285220, 18293137, 18294062, 18313856, 18314250, 18332118, 18337848, 18353117, 18415202, 18415923, 18416945, 18418278, 18419899. Model 8110, Lots: 18421013, 18473202. Model 8111, Lots: 18285930, 18351033, 18353540, 18420652, 18468909 . Model 8112, Lots: 18291473, 18336768, 18355225, 18421690, 18427953. Model 8113, Lots: 18324876, 18324963, 18332278, 18352696, 18358192, 18371973, 18372577, 18440783, 18441697, 18467134, 18468171, 18471598, 18472178, 18478892, 18479477. Model 8114, Lots: 18282143, 18284604, 18335173, 18345117, 18441212, 18442550, 18442887. Model 8115, Lots: 18288704, 18328790, 18329233, 18356691, 18357371, 18357372, 18372837, 18373201, 18377504, 18378867, 18446665, 18447045, 18451382, 18451950, 18452785, 18453099, 18464410, 18473932, 18477470, 18483223, 18483940. Model 8116, Lots: 18281865, 18473055. Model 8117, Lots: 18333920, 18334332, 18466601. Model 8118, Lots: 18316161, 18336837, 18348081. Model 8119, Lots: 18286265, 18291252, 18332911, 18336838, 18347898, 18480844, 18483020, 18471580.

Why it was recalled

Potential for separation of the proximal handle from the shaft.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific personnel began retrieving product from hospital shelves on November 25, 2015. The hospital was given a Medical Device Retrieval letter. The letter provided the reason for product retrieval, identified affected product, asked for product to be segregated to ensure that it will not be used, and to contact Boston Scientific for a return authorization number to ship product back to Boston Scientific. A Certificate of Removal was asked to be completed and emailed to BSCFieldActionCenter@bsci.com Questions can be addressed to Technical Services at 1-800-227-3422.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, and Thailand.

Timeline

Recall initiated: 2015-11-25
Posted by FDA: 2016-01-05
Terminated: 2016-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142058. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.