Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 6

FDA device recall Z-1401-2024 · posted 2024-03-29 · Open, Classified

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention

Action taken

Terumo issued URGENT Medical Device Safety Alert on 2/20/24 via 2-day FedEx delivery. Letter states reason for recall, health risk and action to take: Do not use the valve included in the kit and discard. The clinician could implement clinical changes such as: 1. Place a stopcock in a closed position or a non-vented cap on the luer lock. 2. Replace the line to the reservoir that has the impacted high pressure check valve in it with another equivalent over-pressure line. The High Crack Check Valve (PN 205307A) is not assembled directly into the finished good and can be replaced with a sterilized over-pressure line. contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Terumo Recall Fax: 732-507-9046 or 732-507-9046@efax.com Terumo Recall Email: tcvs.recall@terumomedical.com

Root cause

Process control

Status

Open, Classified

Product code

OEZ

Quantity affected

20,533 units

Distribution

worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.

Date initiated

2024-02-20

Date posted

2024-03-29

Location

Ann Arbor, MI