Medtronic Perfusion Systems recalls DLP Antegrade/Retrograde Adapters with small pinholes in sterile pouch packaging. Seven product variants affected. No remedy specified in official notice.
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Medtronic Perfusion Systems is recalling DLP Antegrade/Retrograde Adapters due to small pinholes in some sterile pouch packaging. This could allow contaminants to enter the sterile packaging during use, potentially causing infection. The recall affects seven specific product variants.
Small pinholes in the sterile packaging could allow contaminants to enter the sterile pouch during use. This poses a risk of infection if the adapter is used in cardiac surgery procedures without proper sterility.
Medical professionals using these adapters during heart surgery are most at risk. The recall applies to specific product variants sold in the U.S. between 2016 and 2017.
Check for the product model number 13001 and lot numbers listed in the recall notice. The adapters were sold between 2016 and 2017 in the U.S. for cardiac surgery procedures.
Look for the model number 13001 and specific lot numbers listed in the recall notice to confirm if your adapter is affected.
The official recall notice does not specify any remedy for this issue.
Seven different product variants were affected by this recall.
The pinholes could allow contaminants to enter the sterile packaging, potentially causing infection during cardiac surgery.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2765-2017 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-2765-2017 from Medtronic Perfusion Systems. 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.
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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.
