Sign up for the QMED & MD+DI Daily newsletter.
March 18, 2015
2 Min Read
In four cases, clinicians observed debris that appeared to come from the device, according to FDA.
Medtronic's FlexCath Select Steerable Sheath, as shown on the company's website
FDA has designated as Class I a Medtronic recall involving the company's FlexCath Select Steerable Sheath (10 Fr Select).
The single-use device is used for percutaneous catheter introduction into the vasculature and chambers of the heart.
Medtronic initiated the recall last month after four reports of clinicians observing debris appearing to originate from the hemostasis valve on the proximal end of Model 990065 of the device, according to FDA. There have been no reports of patient injury or death, nor are any predicted, but potential debris in the heart nevertheless poses a risk of serious injury or death.
In a hand-delivered letter to U.S. customers, Medtronic has requested that they return the affected product.
Material separation appears to be the most frequent problem involving catheter introducers, according to FDA databases.
When Medtronic announced FDA clearance of the FlexCath Advance Steerable Sheath in early 2013, it touted it as a second-generation sheath with an increased degree of deflection and response. The FlexCath, according to Medtronic, provides greater ease compared to the previous generation in reaching the inferior veins of the heart.
Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.
Like what you're reading? Subscribe to our daily e-newsletter.
You May Also Like
Smart Artificial Urinary Sphincter Advances Bid for FDA ApprovalFeb 23, 2024|5 Min Read
Sustainable Manufacturing Expo Hits North AmericaFeb 22, 2024|4 Min Read
Medtronic Doubles Down on Sustainability EffortsFeb 22, 2024|1 Min Read
Top Medical Device M&AFeb 21, 2024|1 Min Read