Abiomed Impella CP 14Fr Introducer Kit 0052-3053Recalls & reported problems
Abiomed, Inc. · Abiomed Impella CP 14Fr Introducer Kit, Long (25cm) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813502011692), received between May 21, 2026 and May 21, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Patient Device Interaction Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2026Fluid/Blood Leak; Patient Device Interaction Problem
AN IMPELLA CP WAS INSERTED VIA THE 14FR INTRODUCER TO SUPPORT (B)(6) MALE PATIENT WHO HAD BEEN ADMITTED IN FOR A PLANNED PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT WAS IN SCAI STAGE E SHOCK AT THE TIME OF PUMP INSERTION. THE PATIENT'S UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE 14FR INTRODUCER WAS NOTED TO BE LEAKING BLOOD FROM THE DIAPHRAGM DURING THE PCI PROCEDURE OF THE LEFT MAIN CORONARY ARTERY. AS THE PATIENT WAS IN CRITICAL CONDITION AND WAS SUFFERING FROM HYPOTENSION THE TEAM MADE DECISION TO LEAVE THE PUMP IN FOR HEMODYNAMIC SUPPORT, BUT PEEL AWAY THE 14FR INTRODUCER. THE INTRODUCER WAS PEELED AWAY AND THE REPOSITIONING SHEATH WAS INSERTED. THE PATIENT HAD BLOOD WORK DRAWN AND THE HEMOGLOBIN WAS FOUND TO HAVE DROPPED FROM 11G/DL TO 6G/DL. THIS LAB DROP AND DIAGNOSIS OF HYPOVOLEMIA, PROMPTED THE TEAM TO INFUSE 2 UNITS OF BLOOD BACK TO THE PATIENT. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. THIS PATIENT WAS KNOWN TO HAVE 9,000 UNITS OF HEPARIN ANTICOAGULATION INFUSED AND THE ACTIVATED CLOTTING TIME WAS 222 SECONDS AT TIME OF THE BLEEDING. THE PUMP SUPPORT WAS EXPLANTED AFTER APPROXIMATELY 20 HOU
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25240408 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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