Search Results for: catheter

ReFlow Medical Issues Recall of Specific Lots of Wingman35 Crossing Catheters

May 3, 2017 By The FDA Leave a Comment

On April 22, 2017, ReFlow Medical initiated a lot-specific voluntary recall of the Wingman35 Crossing Catheters. The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury. The Wingman35 Crossing Catheters have been found to exhibit tip … [Read more...]

Medtronic Announces Voluntary Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters

October 17, 2016 By The FDA Leave a Comment

This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. … [Read more...]

Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters

October 4, 2016 By The FDA Leave a Comment

On September 16, 2016, Vascular Solutions, Inc. (Nasdaq:VASC), initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of … [Read more...]

Cook Medical Issues Global, Voluntary Recall of Catheters with Beacon Tip Technology

May 3, 2016 By The FDA Leave a Comment

On April 15, 2016, Cook Medical initiated a voluntary recall of 4,146,309 catheters with Beacon Tip technology. Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation, which have resulted in 30 Medical Device Reports to date. … [Read more...]

Voluntary Recall of Fetch™ 2 Aspiration Catheter

April 11, 2016 By The FDA Leave a Comment

Boston Scientific (NYSE: BSX) has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. … [Read more...]