ELEMENT Vascular Access System ELMNT17F65-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810169720073), received between Aug 28, 2025 and Sep 17, 2026 — classified as 1 death, 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  The patient underwent a thrombectomy procedure in the pulmonary artery using an Indigo System Flash Aspiration Catheter (Flash Catheter), a Penumbra Engine (Engine), and an Element Vascular Access Sheath (Element). Aspiration thrombectomy was performed for approximately 40 minutes. Follow-up angiography demonstrated near-complete resolution of thrombus within the lower lobar arteries with improved bilateral lower lobe perfusion. Estimated blood loss was 280 mL.Immediately following the procedure, the patient developed profound hypotension with systolic blood pressure in the 50s, lactic acidosis, and acute mental status changes. The patient was treated with Narcan twice and Norepinephrine was initiated. Bedside echocardiography revealed a new moderate-sized pericardial effusion with cardiac tamponade. Emergent pericardiocentesis was performed, removing 240 mL of blood, and a pericardial drain was placed. Repeat computed tomography (CT) scan performed on (b)(6) 2026 showed clot burden was slightly decreased from baseline without evidence of right heart strain. Bedside echocardiography on (b)(6) 2026 demonstrated no pericardial effusion, and the pericardial drain was removed on (b)(6)

  Patient problems: Cardiac Perforation

  MAUDE report 50804966 ↗
• DeathAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR PULMONARY EMBOLISM IN THE BILATERAL PULMONARY ARTERIES USING A CATHETER (PIGTAIL), GUIDEWIRE, AND AN ELEMENT VASCULAR ACCESS SHEATH (ELEMENT SHEATH). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE GUIDEWIRE AND CATHETER BUT WAS UNAWARE THAT THE GUIDEWIRE AND CATHETER WERE POSITIONED IN THE PERICARDIUM. THE PHYSICIAN THEN INSERTED THE ELEMENT SHEATH OVER THE GUIDEWIRE. AT THIS TIME, THE PATIENT DECOMPENSATED, AND A CODE BLUE WAS INITIATED. DURING RESUSCITATION EFFORTS, THE PATIENT WAS ADMINISTERED TISSUE PLASMINOGEN ACTIVATOR (TPA); HOWEVER, THE PATIENT SUBSEQUENTLY EXPIRED. ON 12-AUG-2025, THE PENUMBRA REPRESENTATIVE RECEIVED INFORMATION THAT DURING AN IMAGING REVIEW IN THE DAYS FOLLOWING THE PROCEDURE, IT WAS DETERMINED THAT THE GUIDEWIRE PERFORATED THE PERICARDIUM.

  Patient problems: Cardiac Perforation

  MAUDE report 22911035 ↗