Argon Medical Devices, Inc: Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE)

Hazard

Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

Details from the source

Reason for recall: Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied Distribution: U.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S. (international) to countries of: China, Panama and Trinidad and Tobago Quantity: Total devices 1821 (US=1794 and O.U.S.=27) units Lot/code info: Model Number: 352506070E UDI-DI code: 00886333217151 Lot Numbers: 11633166 11633125 11629543 11629273 11628836

UPC codes

00886333217151

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.