BEUDAMED
    FDA Recall 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

    Recall: Z-1393-2022 · Initiated May 31, 2022

    Recall

    Recall Number
    Z-1393-2022
    Event Number
    90386
    Firm
    Synapse Biomedical Inc
    FEI Number
    3005868392
    Product Code
    OIR
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 31, 2022
    Terminated
    April 11, 2024
    Address
    300 Artino St, Oberlin, OH, 44074-1263

    Description

    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

    Reason

    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).

    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.

    Distribution

    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.

    Quantity

    71