Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 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 (femor
Check against the official notice below — it lists the full affected range.
Cook Medical issued a recall for the Zilver PTX Drug-Eluting Peripheral Stent (6 mm x 80 mm, 125 cm) due to delivery system failures. The company received 13 complaints involving fractures of the inner catheter after stent deployment and separation of the inner catheter tip section, representing an occurrence rate of 0.043%. Two adverse events were associated with tip separation, including one death.
The recalled product was distributed worldwide, including nationwide in the USA (1,057 units), and in Japan, Europe, Brazil, and Australia. The affected stents have reference number ZIV6-35-125-6-80-PTX and lot code REFG24890, with UDI 10827002248905, and include all lots distributed prior to April 16, 2013. The source document does not specify what actions 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: 1,057 units in USA Lot/code info: REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.