Stryker SmartPump tourniquet cuff flanges may detach from the bladder
Stryker SmartPump Tourniquet disposable cuffs are being recalled because the cuff flange may become detached from the bladder, which the manufacturer links to a risk of hemorrhage if a leak occurs during a procedure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: Risk-of-harm product: a tourniquet cuff that may leak during surgery, which the manufacturer links to greater than expected blood loss, with no injury reported.
Plain-English summary
The Stryker SmartPump Tourniquet, disposable sterile single use, is being recalled across catalog numbers 5921-018-135, 5921-018-235 and 5921-024-235. The action covers 233,230 units.
According to the manufacturer, the tourniquet cuff flange may become detached from the bladder. If a leak occurs during the procedure, there may be a risk of hemorrhage resulting in blood loss greater than expected, and the notice lists other serious risks including cerebral hypotension, cardiovascular collapse and arrest, risking stroke or death. The notice also refers to patient toxicity specific to intravenous regional anaesthesia. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was nationwide in the United States and internationally, including to Australia and Canada. The cuffs are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog numbers and GTINs above and follow the instructions issued by Stryker.
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
Distribution
Distributed nationwide across the United States.
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