News | Cath Lab | April 07, 2020

Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment

Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment

April 7, 2020 — Boston Scientific Corp. is recalling its Imager II 5 French angiographic catheters, because there is a potential for the catheter tip to become detached during a procedure or during procedure preparation. 

The U.S. Food and Drug Administration has listed this as a Class I recall. The FDA said there have been nine reported patient injuries due the the problem with the catheters. The FDA said use of the affected product may lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital. 

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

The lots affected include those distribution between July 16, 2018 to Nov. 26, 2019. The number of devices being recalled in the U.S. is 6,130.

On Feb. 11, 2020, Boston Scientific sent a letter to customers informing them of the affected lot numbers and provided the following instructions:
   • Remove any affected lots in the hospital inventory
   • Stop using any product with the affected lot number
   • Complete the Verification Form and include the quantity of units from each affected lot
   • Return the affected lots to Boston Scientific Corporation

Read the FDA recall notice 


Related Content

News | Cath Lab

May 1, 2025 – Analyses from the (Ergonomics in the Cardiac Catheterization Laboratory (ERGO-CATH) study show the ...

Home May 01, 2025
Home
News | Cath Lab

March 17, 2025 — GE HealthCare recently launched the AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab. The AltiX AI ...

Home March 17, 2025
Home
News | Cath Lab

December 20, 2023 — Jason R. McCarthy, Ph.D., associate professor of biomedical research and translational medicine and ...

Home December 20, 2023
Home
News | Cath Lab

October 26, 2023 — Royal Philips, a global leader in health technology, announced the latest results demonstrating the ...

Home October 26, 2023
Home
News | Cath Lab

October 25, 2023 — Shockwave Medical, Inc., a pioneer in the development and commercialization of transformational ...

Home October 25, 2023
Home
News | Cath Lab

October 20, 2023 — Over the coming days, Philips will be presenting its latest solutions in cardiology and new late ...

Home October 20, 2023
Home
News | Cath Lab

October 16, 2023 — GE HealthCare (Nasdaq: GEHC) announced US FDA 510(k) clearance of Allia IGS Pulse - the latest ...

Home October 16, 2023
Home
News | Cath Lab

October 16, 2023 — Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, announced the first U.S ...

Home October 16, 2023
Home
News | Cath Lab

September 13, 2023 — A diagnostic test, first offered in the United States at University Hospitals (UH) Harrington Heart ...

Home September 13, 2023
Home
News | Cath Lab

August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and ...

Home August 02, 2023
Home
Subscribe Now