Alto Development Corp recalls Ultra-Flex Monopolar Pacing Wire (M-21 Series) due to updated instructions for use consistency between electrode IFU and instructions. This temporary cardiac pacing electrode may cause confusion in medical use.
Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
Alto Development Corp recalls specific Ultra-Flex Monopolar Pacing Wire models (M-21 Series) for updated instructions. This affects temporary cardiac pacing equipment used in medical settings. The recall is about consistency between the product's instructions and the manufacturer's guidelines, not a safety hazard.
The recall addresses a discrepancy between the product's instructions for use and the manufacturer's guidelines. This inconsistency could lead to confusion in medical procedures, but it does not pose a direct safety risk to patients or users.
Medical professionals using temporary cardiac pacing equipment with the recalled Ultra-Flex Monopolar Pacing Wire (M-21 Series) are most at risk. Patients receiving this device for temporary cardiac pacing may also be affected.
Check for the product model numbers 021-001, 021-010, or 021-011 on the Ultra-Flex Monopolar Pacing Wire. These were sold with lot numbers 0715A or later for temporary cardiac pacing applications.
Identify if your Ultra-Flex Monopolar Pacing Wire has model numbers 021-001, 021-010, or 021-011.
The recall is for updated instructions for use consistency between the electrode's instructions for use and the manufacturer's guidelines.
No, this recall is about consistency in instructions, not a safety hazard.
Check if your Ultra-Flex Monopolar Pacing Wire has model numbers 021-001, 021-010, or 021-011. If so, contact Alto Development Corp for guidance.
We’ve drafted a message you can send Alto Development Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-2098-2019 — Alto Development Corp Alto Development Corp Hello, I own a Alto Development Corp that is covered by recall Z-2098-2019 from Alto Development Corp. 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.
