HEMASHIELD PLATINUM
Received Mar 19, 2026 · Event occurred Feb 25, 2026
Report 1640201-2026-0000007 · MDR key 24640182
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175430P0Catalog number
M00202175430P0
Lot number
25F11
Product problems
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(10/3233) IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 25F11. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE CUSTOMER OPENED THE HEMASHIELD PLATINUM GRAFT FOR A CASE, HE WASN'T COMFORTABLE USING THE PRODUCT BECAUSE IT LOOKED DIFFERENT IN COLOR THAN THEY ARE USED TO. THEY PUT IT ASIDE AND USED A DIFFERENT GRAFT THAT THEY STATED WAS MORE WHITE.