MalfunctionOFL
TRANSCAROTID/PERIPHERAL ACCESS KIT
Received Jun 30, 2026
Report 1649395-2026-00004 · MDR key 25668177
Device
Product problems
- Material Integrity Problem
Patient
0 DA · Unknown
- Embolism/Embolus
Narrative
Description of Event or Problem
LETTERS ALL GONE, STARTED TO INSERT IT NOT KNOWING WHERE THE 2 1/2 WAS. THEY DROPPED THE ORIGINAL SO THEY OPENED A NEW ONE AND I COULD SEE IT UNTIL IT WAS IN TOO DEEP.
Remedial action
- Recall