A&E Medical Ultra-Flex Pacing Wire Recalled for Instruction Updates
Alto Development Corp is recalling Ultra-Flex MYO/Wire pacing wires to update instructions for use to ensure consistency with the M-21 loop electrode.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is for a documentation issue (updating instructions for use) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor labeling or documentation errors.
Plain-English summary
Alto Development Corp is recalling A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrodes (M-21 Series). The recall involves 351.5 boxes of temporary pacing electrodes, specifically lots 0715A or later. These devices are used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
The recall was initiated to update the instructions for use (IFU) for the Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode. The goal is to ensure the instructions are consistent between the electrode IFU and the instructions for the M-21 loop.
The affected products were distributed in the United States, Czech Republic, Italy, Israel, and the UK. No specific consumer action is detailed in the source text beyond the recall notification.
The recalled product
- Product
- A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex…
- Manufacturer
- Alto Development Corp
- Category
- Medical Device — Cardiac Pacing
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 0715A or later
Distribution
Distributed nationwide across the United States.
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