News | Balloon Catheter | February 24, 2020

Abbott Recalls Two Coronary Balloon Catheters That May Not Deflate

NC Trek RX and the NC Traveler coronary dilatation catheters part of FDA Class I recall 

NC Trek RX Coronary Dilatation Catheter is part of an FDA Class I recall because it may not defalte.

February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters — the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter. The balloons from the impacted lots may not deflate as intended. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall. 

Potential risks of the balloons not deflating include prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional intervention, such as surgery that could lead to post-operative complications, which include death.

The FDA has classified this as a Class I recall. The recalls includes balloon diameters 4 mm, 4.5 mm and 5 mm. The FDA said this recall does not affect patients who have successfully undergone cardiac procedures using these devices.

Abbott issued a field safety notice (FSN) Jan. 29, 2020, to physicians and hospitals who received coronary catheters from the affected lots. The company is arranging the return and replacement of all remaining products. The affected products were manufactured between July 29, 2019, through Dec. 19, 2019, and distributed between Aug. 16, 2019, and Jan. 3, 2020. The total number of distributed units from identified lots potentially affected is 40,429.

The frequency of reported events that include slow, partial and failure to deflate the balloon, is 0.12 percent worldwide. At the time the FSN was issued, there were no reports of patient death. Since the issuance of the FSN, Abbott has become aware of one reported case in which the inability to deflate the balloon necessitated intervention, which resulted in post-procedural complications leading to a patient death.

Healthcare providers that received the Jan. 29, 2020 FSN directed to read the document and follow its instructions.

 

 


Related Content

News | Balloon Catheter

June 13, 2024 — The U.S. Food and Drug Administration (FDA) announced that Teleflex, and their subsidiary Arrow ...

Home June 13, 2024
Home
News | Balloon Catheter

April 4, 2024 — The U.S. Food and Drug Administration (FDA) announced that Medos International Sàrl is recalling ...

Home April 04, 2024
Home
News | Balloon Catheter

January 18, 2024 — Summa Therapeutics, LLC announced that the first-in-man injectable angioplasty procedures for ...

Home January 18, 2024
Home
News | Balloon Catheter
Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional ...
Home February 25, 2022
Home
News | Balloon Catheter

February 15, 2022 – CERENOVUS, an emerging leader in neurovascular care and part of Johnson & Johnson Medical Devices ...

Home February 15, 2022
Home
News | Balloon Catheter

May 20, 2021 — Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the Agent Drug-Coated ...

Home May 20, 2021
Home
Feature | Balloon Catheter | By Dave Fornell, Editor

The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA) ...

Home March 16, 2021
Home
Feature | Balloon Catheter

February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular ...

Home February 17, 2021
Home
News | Balloon Catheter

June 4, 2020 — Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score ...

Home June 04, 2020
Home
News | Balloon Catheter

July 15, 2019 — Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon ...

Home July 15, 2019
Home
Subscribe Now