Impella 0052-3068Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813502011784), received between Mar 17, 2026 and Mar 17, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryMar 17, 2026Break; Fluid/Blood Leak; Device Damaged Prior to Receipt by User

  CLINICAL RATIONALE: A 39-YEAR-OLD MALE WITH POSTCARDIOTOMY CARDIOGENIC SHOCK (PCCS), WHOSE PRE SUPPORT CLINICAL STATUS WAS CONSISTENT WITH SCAI SHOCK STAGE D, UNDERWENT PLACEMENT OF AN IMPELLA 5.5 VIA THE RIGHT AXILLARY ARTERY USING A SURGICAL GRAFT. I WAS CALLED TO THE OR REGARDING A 5.5 CASE, AND UPON ARRIVAL, THE IMPLANTING SURGEON REPORTED ACTIVE BLEEDING FROM THE INTRODUCER WHILE THE GRAFT WAS CLAMPED. A NEW INTRODUCER FROM A DIFFERENT 5.5 BOX (AXILLARY KIT) WAS INSERTED WITHOUT ISSUE. NO BLEEDING OCCURRED WITH THE REPLACEMENT INTRODUCER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE EVENT INVOLVED A TIP SPLIT INTRODUCER NOTED UPON INITIAL USE, LEADING TO BLEEDING AT THE GRAFT SITE. THE REPORTED MAJOR BLEED IS CONSISTENT WITH ACCESS SITE COMPLICATIONS AND THE ANTICOAGULATION/PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. THE DEVICE WAS REMOVED AND REPLACED WITHOUT FURTHER COMPLICATION. ROOT CAUSE REMAINS UNDETERMINED. WHEN THE DEVICE IS RETURNED FURTHER EVALUATION AND ANALYSIS WILL BE PERFORMED. THE PATIENT REMAINS ON SUPPORT AT THE TIME OF REPORTING. UPDATE (B)(6) 2026 A SEPARATE ISSUE OF A BRIEF CONTROLLER ERROR ALARM THAT SELF RESOLVED IS BEING REPORTED. NO FURTHER

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24620434 ↗

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-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-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-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-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-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
• 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-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-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-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-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-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