Last Updated on November 1, 2021 by The Health Master
Cook Medical issued a global, voluntary recall of the following medical devices:
Transseptal Needle with Catheter
This recall includes all unexpired lots for both of these products. The needles (medical device) were recalled due to complaints of rust on the products.
Use of affected medical devices could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death.
The U.S. Food and Drug Administration (USFDA) has not yet classified the recall. A complete list of products affected by this recall can be found below.
Transseptal Needles, including Transseptal Needles with Catheters, were found to have rust internally, externally, or both. To date, Cook Medical has received no reports of injury or illness related to this recall.
Cook has received four complaints where the presence of rust was identified prior to patient contact. However, please be advised that the presence of rust may go undetected by the user. The USFDA and other regulatory agencies around the world have been notified of this action.
Potential adverse events
If an affected product is used, potential negative outcomes include increased procedural time (to obtain a replacement device) and inflammatory reactions ranging from local or self-limited reactions to systemic reactions requiring medical intervention. Systemic reactions could potentially lead to permanent impairment or death.
|INTENDED USE||REFERENCE PART NUMBER (RPN)||ORDER NUMBER (GPN)||LOT NUMBER / UDI||RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS|
|Transseptal Needle||Intended for transseptal left heart access in both diagnostic and interventional procedures||TSNC-18-71.0||G02364||All||October 02, 2016 through July 22, 2021|
|Transseptal Needle with Catheter||Intended to facilitate transseptal entry into the left atrium||TSN-17-75.0-ENDRYS||G19261|
Recall return information
Customers that received products affected by the recall were sent prepaid labels in a recall information packet. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected products to Cook as soon as possible for credit.
Customers in the U.S. and in Latin America should return affected product(s) to Cook Medical. Before returning affected product to Cook Medical, please obtain an RGA#. You may contact 800.457.4500, press option 5, and enter extension 151090 to obtain an RGA# and return address.
Adverse event reporting
Report adverse events to Cook Medical Customer Relations. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
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