The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
FDA Recall Z-0021-2018 · Posted 2017-10-20
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Recalling FirmOriGen Biomedical, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2017-08-02
Date Terminated2024-02-29
Product Quantity180 units
Reason for Recall
Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO
Catheter has had a separation of the clear extension tube from the hub connection. These
adverse events resulted in patient injury (blood loss).
Firm Action
The firm initiated their recall by letter on 08/02/2017, following with a press release on 08/28/2017. The firm sent a revised letter to include instructions for the distributors on 09/22/2017 and an updated press release was sent on 09/26/2017. The firm requested that the consignee discontinue use of all OriGen VV28F Reinforced Dual Lumen ECMO Catheters from lots N18487 and N18487-1 and return any of those lots to OriGen Biomedical immediately for replacement or product credit.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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