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Terminated

NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

FDA Recall Z-1393-2022 · Posted None

Recalling FirmSynapse Biomedical Inc
Recall StatusTerminated
Product CodeOIR
Date Initiated2022-05-31
Date Terminated2024-04-11
Product Quantity71

Reason for Recall

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).

Firm Action

On May 31, 2022, the firm began to contact all affected customer sites. Customers were informed that the way the temperature storage conditions are stated on the labeling of these devices could lead to improper storage that, under certain circumstances, could damage the devices. Synapse will visit customer facilities to place a label with proper storage conditions over the current storage conditions on the device label. Customers who would rather not have a site visit may destroy their devices and Synapse will replace them. The firm will also provide a revised Surgeon Instruction Manual that includes a description of the storage temperature symbol.

Root Cause

Labeling design

Distribution Pattern

Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV. Foreign distribution pending.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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