Stryker SmartPump Tourniquet cuff flange may detach during surgery
Stryker SmartPump Tourniquet cuff flanges may detach during use, causing potential hemorrhage and cardiovascular collapse. Distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm surgical device where injury has not yet been reported. While the potential consequences (hemorrhage, cardiovascular collapse, death) are serious, the source text describes these as theoretical risks rather than realized harms.
Plain-English summary
Stryker Corporation has recalled certain SmartPump Tourniquet disposable sterile units due to a manufacturing defect. The cuff flange may become detached from the bladder, potentially causing a leak during surgical procedures.
If a leak occurs during tourniquet use, there is a risk of hemorrhage with blood loss greater than expected during the procedure. Additional serious risks include cerebral hypotension and cardiovascular collapse or arrest, which could result in stroke or death. In intravenous regional anesthesia (IVRA) procedures specifically, patients may also experience toxicity due to rapid systemic absorption of anesthetics caused by the device failure.
The recall affects three product codes distributed domestically throughout the United States and internationally to Australia, Canada, Hong Kong, India, Malaysia, Netherlands, New Zealand, Singapore, Sweden, Thailand, and the United Kingdom. A total of 233,230 units have been identified as part of this recall.
Healthcare facilities and surgical centers using these tourniquets should discontinue use immediately and contact Stryker for replacement or return guidance. Any reports of device failure, patient injury, or complications should be reported to the FDA.
The recalled product
- Product
- Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
- Manufacturer
- Stryker Corporation
- Hazard
- device-malfunction
- hemorrhage
- cardiovascular-collapse
- anesthetic-toxicity
Distribution
Distributed nationwide across the United States.
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