Covidien recalls Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin) with CFN SIGSDL45CTVT due to potential uncontrolled motion from a manufacturing issue.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Covidien is recalling a specific type of vascular catheter that could move unexpectedly during use, which might cause injury. This recall affects certain model numbers and lot numbers sold between specific dates.
A manufacturing defect can cause the catheter's cover tube to become malformed. This may lead to internal components moving unexpectedly during use, potentially causing uncontrolled motion.
Medical professionals using the Signia Small Diameter Curved Tip Intelligent Reload catheter are most at risk. Patients receiving this device during procedures may also be affected.
Check for the model name 'Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin)' and the CFN code SIGSDL45CTVT. Lot numbers N5F1971Y, N5F1723Y, N5D1858UY, and N5B1134UY are also affected.
Identify the model name, CFN code, and lot numbers to confirm if your device is affected.
The recall states a potential risk of uncontrolled motion from a manufacturing issue, but the exact danger level is not specified in the record.
Check for the model name 'Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin)', CFN code SIGSDL45CTVT, and lot numbers N5F1971Y, N5F1723Y, N5D1858UY, or N5B1134UY.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0485-2026 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0485-2026 from Covidien. 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.
