Medtronic recalls specific ClearView intracoronary shunt models due to potential unsealed sterile packing. Affected units include 1.00mm (model 31100), 1.25mm (31125), and 2.00mm (31200) shunts with certain lot numbers. Contact Medtronic for details.
Potential for unsealed sterile packing.
Medtronic is recalling specific ClearView intracoronary shunts that may have unsealed sterile packaging. This could lead to contamination during medical procedures if the shunt is used without proper sterilization.
The shunts may have unsealed sterile packaging, which could allow contamination during medical procedures. This poses a risk of infection or improper sterilization if the shunt is used without proper handling.
Healthcare professionals using these shunts for cardiac procedures are most at risk. Patients receiving these shunts during surgery may be affected if the packaging is compromised.
Check for model numbers 31100, 31125, or 31200 on the shunt packaging. Look for specific lot numbers and GTINs listed in the recall notice.
Identify the model number and lot numbers on the shunt packaging to confirm if it is affected.
The recall indicates a potential risk of unsealed sterile packaging, but the shunts are not inherently unsafe. Affected units should be checked for specific model and lot numbers.
Contact Medtronic directly to confirm if your shunt is affected and follow their instructions for next steps.
Check the model number (31100, 31125, or 31200) and lot numbers listed in the recall notice.
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-1803-2024 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-1803-2024 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.
