Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chord-X Chordal Sizer is designed to assist in determining the Recalled by On-X Life Technologies, Inc. Due to Four issues were uncovered by the recalling firm's...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact On-X Life Technologies, Inc. directly.
Affected Products
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
Quantity: 45 units
Why Was This Recalled?
Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptably press-fit together, was discovered within one sealed primary package. One of the Left Housing press-fit pins was not pressed into the associated hole of the Right Housing, resulting in a small gap in the housing assembly.
Where Was This Sold?
This product was distributed to 7 states: CA, DE, ME, NE, OH, TX, WA
About On-X Life Technologies, Inc.
On-X Life Technologies, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report