Events

Recall of Device Recall AngioJet Spiroflex Thrombectomy Set

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
    71849
  • Event Risk Class
    Class 2
  • Event Number
    Z-2377-2015
  • Event Initiated Date
    2015-07-31
  • Event Date Posted
    2015-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139220
  • 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, embolectomy - Product Code DXE
  • Reason
    Angiojet products were distributed with an incorrect use-by (expiry) date. the correct date is nov-2015, but the units are labeled with a use-by date of dec-2015.
  • Action
    Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 31, 2015, to all affected consignees. The letter described the problem and the affected product. Consignees were advised to segregate the affected product and return it to Boston Scientific. They were also requested consignees to complete and return the Account Reply Verification Tracking Form. Contact your Sales Representative for any questions. For questions regarding this recall call 763-494-1556.

Device

Device Recall AngioJet Spiroflex Thrombectomy Set
  • Model / Serial
    163580
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
  • Product Description
    AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 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