Home / Recalls / Volcano Corp / Z-1270-2022

Z-1270-2022 Class II Terminated

Recalled by Volcano Corp — San Diego, CA

Recall Details

Product Type
Devices
Report Date
June 22, 2022
Initiation Date
May 16, 2022
Termination Date
December 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 devices

Product Description

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Reason for Recall

Due to a potential failed sterilization process.

Distribution Pattern

U.S.: WA and WI O.U.S.: Canada

Code Information

Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719

Other recalls by Volcano Corp

  • Z-2221-2025 Class II — Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P (June 13, 2025)
  • Z-1302-2022 Class III — Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx O (May 13, 2022)
  • Z-1301-2022 Class III — Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Onl (May 13, 2022)
  • Z-0917-2022 Class III — MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbe (February 3, 2022)
  • Z-0901-2022 Class III — IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30000 (January 24, 2022)
  • Z-2044-2015 Class II — Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System (September 23, 2013)
  • Z-2043-2015 Class II — Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; (September 23, 2013)
  • Z-2045-2015 Class II — ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Ma (September 23, 2013)