Spectranetics recalled more than 1,900 Bridge Occlusion Balloon Catheters due to a product flaw that may prevent the device from working properly.
Here are five things to know.
1. Some recalled devices may contain a blocked guidewire lumen. The defect would prevent clinicians from properly positioning the device and delay life-saving treatment to control hemorrhaging.
2. The recall applies to catheters distributed between Feb. 24 and July 31.
3. Spectranetics first warned clinicians of the potential product flaw Aug. 7, urging clinicians to assess the device and ensure the guidewire lumen is unblocked prior to using the catheter.
4. The company sent out a second notice Aug. 21, saying the product flaw could occur in any Bridge Occlusion Balloon Catheter.
5. Spectranetics will arrange for the return and replacement of affected catheters once the product issue is permanently resolved.
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