Medtronic Bio-Medicus Femoral Cannula/Introducer

• • Terminated Z-1928-2008 FDA Unclassified (pre-2012) ·initiated 9 May 2008

  Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).

510(k) Number

K924642 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• BPX80 Bio-Pump (BPX80)

  Class II

  FDA 510(k) K973011 Active Cleared 25 Feb 1998

• Bio-Probe(R) Blood Flow Monitoring Syst(Tx-50/50P)

  Class II

  FDA 510(k) K924208 Active Cleared 8 Jul 1993

• Medtronic Bio-Medicus Cannula Insertion Kit

  Class II

  FDA 510(k) K924643 Active Cleared 8 Dec 1992

• Medsat Oxygen Saturation System

  Class II

  FDA 510(k) K941922 Active Cleared 17 Feb 1995

• Medtronic Bio-Medicus Bio-Console Model 540-D

  Class II

  FDA 510(k) K914754 Active Cleared 20 May 1992

• Biotrend Oxygen Saturation & Hematocrit System

  Class II

  FDA 510(k) K954501 Active Cleared 16 Jan 1996

See all devices from Medtronic Bio-Medicus, Inc. →