Oscor recalls TB Series Bipolar Pacing Leads with 2mm unshrouded connectors for potential connector cap sliding, risking wire breakage during movement.
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
Oscor is recalling TB Series Bipolar Pacing Leads with 2mm unshrouded connectors because the connector cap housing may slide, potentially exposing the connection wire. This could cause the wire to break or lose connectivity during movement, disrupting the pacing system.
The 2mm unshrouded connectors have a cap housing that can slide, exposing the connection wire. During movement, this may cause the wire to break or lose connectivity, interrupting the pacing system.
Patients using these specific pacing leads for heart rhythm management are most at risk. The recall affects medical devices used in cardiac procedures.
Check for TB Series Bipolar Pacing Leads with French Sizes 4F, 5F, or 6F, and specific curve types including Straight, Atrial J, or 60-degree Curve. The product is labeled with model numbers like 020004, 020005, or 020006.
Look for the model number on the lead, such as 020004 for 4F size, to confirm if it's in the recalled list.
If you have the recalled leads, contact Oscor directly for instructions on how to return or replace them.
The recall indicates a potential risk of connector cap sliding, but the leads are not unsafe for normal use. The manufacturer recommends checking if they are in the recalled list.
Check the model number on the lead, such as 020004 for 4F size, to see if it matches the listed recall items.
Contact Oscor directly for instructions on returning or replacing the leads.
We’ve drafted a message you can send Oscor to request your refund or repair — edit it as you like.
Subject: Recall Z-0391-2019 — Oscor Oscor Hello, I own a Oscor that is covered by recall Z-0391-2019 from Oscor. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
