Events

Safety Alert for Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Vascular Solutions.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-09-21
  • Event Date Posted
    2016-09-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160921.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: vascular solutions twin-pass, twin-pass rx and twin-pass .023" catheters medical device manufacturer, vascular solutions, inc., has issued a medical device safety alert concerning its twin-pass, twin-pass rx and twin-pass .023" catheters. [model numbers: 5200, 5210, 5230; lot numbers: 575653, 577278, 577279, 577761, 577762, 578419, 578996, 578997, 579472, 5797s7, 580186, 580612, 580613, 581252, 582138, 582579, 582580, 583021, 583785, 584155, 584156, 584463, 584812, 585176, 585784, 585785, 586310, 586399, 587030, 587407, 587772, 588499, 588542, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 590739, 591037, 591261, 591262, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593696, 593717, 593985, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037]. the manufacturer has become aware of a potential problem with their twin-pass (5200), twin-pass rx (5210) and twin-pass .023” (5230) dual access catheters. investigation concluded that there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. it is possible that the excess material may separate from the catheter during a procedure, which poses a potential risk of an embolism to the patient. according to the manufacturer, there have been no reports of adverse patient events related to this issue. the manufacturer is voluntarily recalling and replacing all affected units of twin-pass, twin-pass rx and twin-pass .023”. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 september 2016.

Device

Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: Vascular Solutions Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters
  • Manufacturer
    Vascular Solutions

Manufacturer

Vascular Solutions