Applied Medical Direct Drive Clip Applier Recalled for Inconsistent Application
Applied Medical Resources Corp is recalling Direct Drive Clip Applier CA090 units due to inconsistent clip application that may lead to unoccluded vessels.
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: The recall involves a medical device defect that may lead to unoccluded vessels (bleeding), which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Applied Medical Resources Corp is recalling the Direct Drive Clip Applier CA090, a medical device indicated for the ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The recall affects 559,274 units distributed individually and in kits across the United States and numerous foreign countries.
The recall was initiated due to increased customer complaints indicating inconsistent clip application. This defect may lead to unoccluded vessels, which poses a risk of bleeding during or after surgical procedures.
Healthcare providers and consumers should stop using the affected devices immediately. The recall includes specific lot numbers for the Direct Drive Clip Applier CA090 and various kit lots containing the recalled applier. Users should contact Applied Medical Resources Corp for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 559,274
Distribution
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