United States
Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. The needles were recalled due to complaints of rust on the products. Use of affected products 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 (FDA) has not yet classified the recall. Products affected by this recall are:
- Transseptal Needle, INTENDED USE: Intended for transseptal left heart access in both diagnostic and interventional procedures, RPN: TSNC-18-71.0 GPN: G02364 and RPN: TSNC-19-56.0 GPN: G02365, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
- Transseptal Needle with Catheter, INTENDED USE: Intended to facilitate transseptal entry into the left atrium, RPN: TSN-17-75.0-ENDRYS, GPN: G19261, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
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 FDA 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.
Check the full recall details on
www.fda.gov
Source: FDA
