Home / Recalls / Medtronic Vascular / Z-2655-2019

Z-2655-2019 Class I

Recalled by Medtronic Vascular — Danvers, MA

Recall Details

Product Type
Devices
Report Date
October 9, 2019
Initiation Date
March 15, 2019
Termination Date
April 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
117 units

Product Description

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular use

Reason for Recall

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Distribution Pattern

Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

Code Information

GTIN: 00613994823366 All Lot/Serial Numbers

Other recalls by Medtronic Vascular

  • Z-1042-2022 Class II — Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, R (March 23, 2022)
  • Z-1043-2022 Class II — Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, (March 23, 2022)
  • Z-0657-2022 Class II — Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant (December 21, 2021)
  • Z-0291-2022 Class II — Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2 (October 15, 2021)
  • Z-0290-2022 Class II — Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF252 (October 15, 2021)
  • Z-0292-2022 Class II — Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF (October 15, 2021)
  • Z-2136-2021 Class II — Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft (June 7, 2021)
  • Z-2135-2021 Class II — Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graf (June 7, 2021)
  • Z-1860-2021 Class I — Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, (May 4, 2021)
  • Z-1976-2021 Class II — Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For (April 28, 2021)