Impella 0052-0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813502011319), received between Sep 28, 2026 and Sep 28, 2026 — classified as 1 death.

13 other recalls cover devices cleared under the same FDA submission (K201116); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  An Impella RP was inserted percutaneously via the right femoral vein in a 72-year-old female patient with coronary artery disease. The patient was classified as SCAI Shock Stage A prior to support initiation, indicating a hemodynamically stable patient at risk for developing cardiogenic shock.During the procedure, the Impella RP became dislodged and migrated into the right ventricle during removal of the peel-away sheath. The device was subsequently removed due to the event. During an attempt to insert a new sheath, perforation of the femoral vein occurred, resulting in significant vascular injury and bleeding from the groin/femoral vein. The patient required vascular repair and transfusion of six units of red blood cells; however, bleeding could not be controlled. The patient subsequently developed hemorrhagic/hypovolemic shock and expired on the same day as implant and explant.Due to the significant blood loss from the venous perforation during the sheath reinsertion the device is considered to have contributed to the patient outcome of death.Additional information received on 16SEP2026 indicated: The reason for inserting the second sheath was, to limit the bleeding of the vein a

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemia; Perforation of Vessels

  MAUDE report 50913432 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201116. One submission often covers many models, so check the product and lot details in each record.

• Z-2687-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2693-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
• Z-2688-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2686-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and acces
• Z-2684-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
• Z-2692-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
• Z-2691-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
• Z-2685-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and acces
• Z-2689-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
• Z-2681-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
• Z-2683-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump an
• Z-2682-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
• Z-2690-2026 · Jun 11, 2026 · Open, Classified
  ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories