Socrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.
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 a risk-of-harm product involving a device used for acute stroke intervention with a manufacturing defect that could compromise sterile barrier integrity and lead to infection. No illnesses or injuries have been reported. The FDA Class II classification and theoretical nature of the hazard support a High severity rating.
Plain-English summary
Scientia Vascular, Inc. is recalling 120 Socrates 38 Aspiration Catheters (catalog number SC038-127-001) due to a manufacturing defect. These devices, measuring 127 cm in length, are intended to be used with a compatible suction pump for revascularization treatment of patients with acute ischemic stroke.
The recall was initiated after discovery of a manufacturing non-conformance that created channels in the seal of the packaging pouch. This defect could potentially compromise the sterile barrier that protects the device from contamination during storage and handling prior to use.
Affected devices bear the lot numbers 030471, 030317, 030345, 030376, 030427, and 030451. The recalled devices were distributed nationwide to healthcare facilities in Alabama, Arizona, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin, and West Virginia.
Healthcare providers and facilities that have received any of these devices should immediately verify whether their inventory is affected using the provided lot numbers. Recalled devices should not be used. Contact Scientia Vascular, Inc. for instructions on proper handling, documentation, and return of affected units.
The recalled product
- Product
- Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
- Manufacturer
- Scientia Vascular, Inc.
- Category
- Medical Device
- Hazard
- sterile-barrier-defect
- contamination-risk
Distribution
Distributed nationwide across the United States.
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