Arterial Cannula Curved Beveled Tip

• • Ongoing Z-0986-2025 FDA Class II ·initiated 12 Dec 2024

  Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

• • Ongoing Z-1793-2024 FDA Class II ·initiated 19 Mar 2024

  Potential for unsealed sterile packing.

• • Terminated Z-1927-2008 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

K840002 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Infant Vent Catheter 12001 W/Side Vent Open recall

  Class II

  FDA 510(k) K834039 Active Cleared 3 Jan 1984

• Submission Coronary Cannula

  Class II

  FDA 510(k) K821149 Active Cleared 18 May 1982

• Percutaneous Guidewire Placement Syringe 50505

  Class II

  FDA 510(k) K855089 Active Cleared 18 Feb 1986

• Clearview Blower/Mister Open recall

  Class II

  FDA 510(k) K973485 Active Cleared 8 Dec 1997

• Dispossable Suction Tube, 6 French

  Class II

  FDA 510(k) K791846 Active Cleared 2 Oct 1979

• Aortic Root Cannula W/Integral Press

  Class II

  FDA 510(k) K831591 Active Cleared 30 Jun 1983

See all devices from Dlp, Inc. →