All Articles Tagged With: "Catheter Recall"
Articles
Transseptal Sheath Introducer Kit Recall: Risk Tip May Break Off
A Class 1 medical device recall has been issued for Transseptal Sheath Introducer Kits by Thomas Medical Products, a subsidiary of General Electric’s healthcare division, because the sheath tips can break off during heart procedures, potentially causing permanent injury or death.
Safesheath CSG Sheath Introducer Recall: Risk of Fracture
A Class 1 medical device recall has been issued for Safesheath CSG Sheath Introducer Systems by Thomas Medical Products, Inc. due to reports that the tip of the sheath can break off and enter patients’ blood vessels.
Becton Dickinson IV System Recall Issued After Patient Fatality
A medical device company is recalling 7.8 million catheters and intravenous (IV) fluid delivery system components after receiving reports of at least one possible death related to the products.
ev3 Endovascular Trailblazer Support Catheter Recall: Device May Crack
The FDA announced this week a recent class I recall that was issued by ev3 Endovascular, Inc. for their Trailblazer Support Catheter, as the device could crack and potentially cause patients to suffer a heart attack, unnecessary surgery, damage to blood vessels or other potentially life-threatening injuries.
ViperSheath Introducer Recall: Reports of Stretching or Fractures of Sheath
A recall has been issued for all lots of the ViperSheath Sheath Introducer for catheters after the manufacturer received reports of the sheaths stretching or fracturing during use. A similar catheter sheath introducer recall was issued for the same reasons last month for the Cordis Crossover, as this could cause fragments to ender the [...]
Aortic Balloon Catheter Recall: May Rupture During Surgery
A Class I recall has been issued for Edwards Lifesciences CardioVations EndoClamp Aortic Catheters, which are used during heart bypass surgery. The FDA and device manufacturer indicate that the balloon catheters may rupture during surgery, potentially causing a fatal injury for the patient.
Cordis Crossover Catheter Sheath Introducer Recall Issued
A recall has been issued by Cordis Corporation for their Crossover Sheath Introducer for catheters, which has been found to stretch or fracture. This could cause fragments to enter the bloodstream and potentially cause an embolism or other life-threatening injury.
Penumbra Catheter Recall Issued for Neuron 6F 070 Delivery Catheter
Older versions of Penumbra Inc.’s Neuron 6F 070 Delivery Catheter have been recalled in the wake of reports that some catheters have kinked, ovalized or broken, resulting in injuries.
Medtronic Infusion Pump Catheter Recall Due to Mislabeled Leads
The FDA has issued a Class I recall for Medtronic Sutureless Connector (SC) intrathecal catheters because they may be incorrectly labeled as being compatible with the IsoMed Infusion pump, a drug delivery system for which the catheters were not designed.
Abbott Catheter Recall: Powersail Coronary Dilation Catheters
The FDA has classified a recall issued by Abbott for their Powersail Coronary Dilation Catheters as a “class 1” recall, meaning that continued use of the catheters could potentially lead to serioud injury or death.
