Arrow recalls temporary pacing catheter kits marketed without 510K clearance. This device is for electrophysiology studies and may not meet safety standards.
Marketed without a 510K
Arrow is recalling temporary pacing catheter kits that were marketed without proper regulatory clearance. This could mean the device doesn't meet safety standards for medical use.
The device was marketed without 510K clearance, which is a regulatory requirement for medical devices in the U.S. This means it may not have undergone the necessary safety testing before being sold. As a result, the device could pose unverified risks during medical procedures.
Healthcare professionals using these catheter kits for electrophysiology studies are likely affected. Patients receiving these procedures may be at risk if the device is used without proper clearance.
Check for product code AI-07155-IK on the kit. Lot numbers 23F20A0230, 23F20E0004, and 23F20E0094 are associated with this recall.
Look for product code AI-07155-IK on the catheter kit.
Reach out to Arrow International for further assistance with the recall.
The device was marketed without 510K clearance, which is a regulatory requirement for medical devices in the U.S. This means it may not have undergone necessary safety testing.
Lot numbers 23F20A0230, 23F20E0004, and 23F20E0094 are associated with this recall.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-2071-2021 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-2071-2021 from Arrow. 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.
