There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Ev3
Class I - Dangerous
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Class I - Dangerous
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Class I - Dangerous
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.
Class I - Dangerous
Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.