Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoro
Check against the official notice below — it lists the full affected range.
Cook Medical has recalled the Zilver PTX Drug-Eluting Peripheral Stent (7 mm x 80 mm; 125 cm) due to problems with its delivery system. The company received 13 complaints involving fractures of the delivery system's inner catheter after stent deployment and separation of the inner catheter tip section, representing an occurrence rate of 0.043%. Two adverse events occurred in cases involving tip separation, including one death.
The affected product was distributed worldwide, including throughout the USA and in Japan, Europe, Brazil, and Australia. In the USA, 535 units were affected. The recalled stents are identified by reference number REF ZIV6-35-125-7-80-PTX and UDI 10827002248950, with all affected lots distributed through April 16, 2013. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation
Reason for recall: Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation Distribution: Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia Quantity: 535 units in USA Lot/code info: REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.