Recall of Arrow Percutaneous Sheath Introducer Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International Inc.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Arrow is recalling the arrow¿ percutaneous sheath introducer kits due to dilator tip damage noted during internal inspection. dilator tip damage has the potential to result in vessel damage.
  • Action
    Teleflex/Arrow International sent an Urgent Medical Device Recall Notification letter dated April 17, 2014, to distributors and end users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product and to complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935 to return product. Customers would be contacted by a customer service representative for a Return Goods Authorization (RGA) Numbers and would be provided instructions for the return of the product. Customers should complete the form whether they have affected product or not. Customers with questions were instructed to call 1-800-343-2935. For questions regarding this recall call 610-378-0131.


  • Model / Serial
    Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Product Description
    Arrow¿ Percutaneous Sheath Introducer Kits || The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
  • Manufacturer


  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
  • Source