Events

Recall of Device Recall Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72739
  • Event Risk Class
    Class 2
  • Event Number
    Z-0588-2016
  • Event Initiated Date
    2015-11-25
  • Event Date Posted
    2016-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142058
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, percutaneous - Product Code DQY
  • Reason
    Potential for separation of the proximal handle from the shaft.
  • Action
    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.

Device

Device Recall Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • 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 .
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA