Synapse Biomedical recalls NeuRx Diaphragm Pacing System components due to revised labeling for storage temperature conditions. Affected parts include system kits and patient surgical kits with specific part numbers and serial ranges.
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).
Synapse Biomedical is recalling certain NeuRx Diaphragm Pacing System (NeuRx DPS) components because the labeling was updated to clarify that temperature symbols indicate storage conditions, not transport or package tolerance. This recall does not pose a safety risk but ensures proper handling instructions.
The recall addresses a labeling clarification to ensure users understand that temperature symbols on the device indicate storage conditions, not transport conditions or tolerance for packaging materials. This update prevents confusion about how to safely handle the device components.
Patients using NeuRx Diaphragm Pacing System implants with affected part numbers, including system kits and surgical components. Healthcare providers and patients who have received the recalled parts are most at risk.
Check for part numbers 20-0035, 20-0036, and other listed components with specific serial numbers and lot codes in the recall list. The affected products were marketed under HDE H070003 and H100006.
Check the device packaging for updated temperature symbols indicating storage conditions.
The recall clarifies that temperature symbols on the device indicate storage conditions, not transport conditions or tolerance for packaging materials.
No, this recall does not require stopping use; it only updates labeling for better storage understanding.
Affected part numbers include 20-0035 (NeuRx DPS System Kit), 20-0036, and other components with specific serial numbers listed in the recall.
We’ve drafted a message you can send Synapse Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1393-2022 — Synapse Biomedical Synapse Biomedical Hello, I own a Synapse Biomedical that is covered by recall Z-1393-2022 from Synapse Biomedical. 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.
