Medtronic recalls Confida Expandable Sheath (REF CES122230) due to increased risk of bleeding, hematoma, and dissection. All units with UDI 00763000233815 are affected.
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Medtronic is recalling its Confida Expandable Sheath (REF CES122230) because it may cause bleeding, hematoma, or vessel damage during medical procedures. This affects all units with the unique identifier UDI 00763000233815.
The sheath can cause bleeding, hematoma (blood clots under the skin), or vessel damage when inserted into the femoral or iliac arteries. This risk occurs during medical procedures that require catheter placement.
Healthcare professionals using this sheath during vascular procedures are most at risk. Patients receiving these procedures may also be affected if the sheath is used improperly.
Check for the unique identifier (UDI) 00763000233815 on the sheath. All units with this identifier are affected, regardless of lot number.
Look for the unique identifier (UDI) 00763000233815 on the sheath to confirm if it is recalled.
Yes, this sheath is used for catheter placement in the femoral or iliac arteries during medical procedures.
The sheath may cause bleeding, hematoma, or vessel damage during insertion into the femoral or iliac arteries.
Check for the unique identifier (UDI) 00763000233815 on the sheath. All units with this identifier are affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2039-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2039-2020 from Medtronic. 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.
