Stryker Neptune 1 Silver Rover Recalled for Tissue Injury and Fatality
Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly reports a fatality and serious injuries, which meets the rubric criteria for a Critical (Score 5) severity rating.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 2,657 units of the Neptune 1 Silver Rover (Part 0700-003-000) and associated Instruction for Use (IFU) materials. The recall covers devices distributed nationwide in the United States and in Canada. The recall is prompted by two reports of serious injury resulting from tissue damage associated with the use of the Neptune 2 system, including one event where a customer connected the system to a passive chest drainage tube post-operatively, resulting in a fatality. The original IFU did not specifically warn against connecting high vacuum/high flow Neptune Waste Management devices to passive drainage tubes.
Further investigation revealed that the Neptune 1 Silver, Neptune 2 Ultra (120V), and Neptune 2 Ultra (230V) lacked FDA 510(k) clearance, meaning they were not legally marketed without a determination of safety and effectiveness. Consequently, the FDA advises that these devices not be used. However, customers who do not have an alternative device available are advised to weigh the risks and benefits of continued use. If customers choose to continue using the Neptune 1 Silver, Neptune 2 Ultra (120V), or Neptune 2 Ultra (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012. Warning labels are pending distribution and are required on all Neptune devices.
The recalled product
- Product
- Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 2,657
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 (2)
- Part 0700-003-000
- all lot numbers IFU 0700-003-000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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