Reported Jul 27, 2022 · Terminated

NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036…

Synapse Biomedical Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synapse Biomedical Inc · 300 Artino St · Oberlin, OH · 44074-1263

Is this the product you have?

NeuRx Diaphragm Pacing System (NeuRx DPS)
Affected part numbersPart # 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

Lot codes and dates: UDI-DI
00852184003007
00852184003045
00852184003038
00852184003267
00852184003090
00852184003106
00852184003113
00852184003120
00852184003137
00852184003144
00852184003151
00852184003168
00852184003175
00852184003182
00852184003281
00852184003052
Lots/Serial Numbers
70 of 70 codes
20-0035-113021-3-3
20-0035-120221-2-1
20-0035-121621-5-2
20-0035-121621-5-3
20-0035-010722-5-4
20-0035-010722-5-5
20-0035-030722-2-2
20-0035-031122-5-1
20-0035-031122-5-2
20-0035-031122-5-5
20-0035-033122-5-1
20-0035-033122-5-2
20-0035-033122-5-3
20-0035-040622-4-1
20-0035-040622-4-2
20-0035-040622-4-3
20-0035-040622-4-2
20-0035-042122-1-1
20-0028-060221-5
20-0028-062421-5
20-0028-062521-5
20-0028-072821-5
20-0028-031022-5
20-0040-012221-10
20-0040-012221-10
20-0040-021921-9
20-0040-012221-10
20-0040-012221-10
20-0040-021921-9
20-0040-021921-9
20-0040-021921-9
20-0040-021921-9
20-0040-012621-10
20-0040-012621-10
20-0040-012621-10
20-0040-012621-10
20-0040-060221-5
20-0040-060221-5
20-0040-060221-5
20-0040-060221-5
20-0040-060221-5
20-0040-060821-5
20-0040-060821-5
20-0040-060821-5
20-0040-060821-5
20-0040-060821-5
20-0040-071321-6
20-0040-071321-6
20-0040-092021-10
20-0040-092021-10
20-0040-071521-2
20-0040-092021-10
20-0040-092021-10
20-0040-092021-10
20-0040-100721-10
20-0040-100721-10
20-0040-100721-10
20-0040-100721-10
20-040-100721-10
20-0040-100721-10
Amount recalled: 71

Where it was sold

Why it was recalled

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).

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where it was sold

Why it was recalled

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