Recalls

4.1 Million Catheters Have Been Recalled

If you have a catheter related injury, you may be entitled to a cash award.

Below is a partial list of recalled catheters


May 3, 2017

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 splitting or separation, which has resulted in two adverse events.

FDA Safety Recall

May 3, 2016

On May 3rd, 2016, the Cook Medical announced a recall of 4.1 million catheters. The following catheters are included in their latest recall.

List of affected catheters with Beacon Tip Technology:

  • Beacon® Tip Torcon NB® Advantage Catheter
  • Beacon® Tip Royal Flush® Plus High-Flow Catheter
  • Beacon® Tip Centimeter Sizing Catheter
  • Beacon® Tip White Vessel Sizing Catheter
  • Beacon® Tip Vessel Sizing Catheter
  • Shuttle® Select Slip-Cath® Beacon® Tip Catheter
  • FluoroSet® Radiographic Tubal Assessment Set
  • Haskal Transjugular Intrahepatic Portal Access Set
  • Kumpe Access Catheter
  • Liver Access and Biopsy Needle Set
  • Neff D'Agostino Percutaneous Access Set
  • Aprima™ Access Nonvascular Introducer Set
  • Selective Salpingography Catheter with Beacon® Tip
  • Transluminal Biliary Biopsy Forceps Set
  • White Lumax® Guiding Coaxial Catheter

FDA Safety Recall

April 8, 2016

Boston Scientific announced a global recall of all models of Fetch 2 Aspiration Catheters. The shaft of the Fetch 2 catheters has been reported to break and has a chance of serious adverse health consequences or death.

FDA Safety Recall

February 10, 2016.

Cook Medical announced another catheter recall for Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays. 17,827 devices have been recalled globally in this recall.

FDA Safety Recall

October 9, 2015

Cook Medical expands recall to include select sizes of Beacon® Tip Angiographic Catheters. This recall is an expansion of the voluntary lot-specific recall issued on July 2, 2015. See April 15, 2016 recall notice for details.

FDA Safety Recall

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