Impella 0046-0035Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 00813502011869), received between Apr 17, 2023 and Apr 24, 2026 — classified as 37 deaths, 74 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (55 reports).

4 FDA recall records name this device's identifier, 4 still open.

15 other recalls cover devices cleared under the same FDA submission (P170011); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 27, 2026Open, Classified

   Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

   Z-1469-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Dec 12, 2024Open, Classified

   Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

   Z-0829-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. Dec 27, 2023Open, Classified

   IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

   Z-0980-2024 · Root cause: Labeling Change Control · FDA record ↗

4. Dec 27, 2023Open, Classified

   New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

   Z-1074-2024 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Failure to Advance

  CLINICAL NARRATIVE: AN IMPELLA RP WAS INSERTED VIA THE LEFT FEMORAL VEIN TO SUPPORT, ALONG WITH THE LEFT SIDED IMPELLA FOR A BIPELLA SUPPORT, FOR THE 57 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH CARDIOMYOPATHY. THE OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PATIENT SUPPORT WAS NOT SUCCESSFULLY PLACED DUE TO NATIVE TORTUOUS ANATOMY. THE RP WAS EXPLANTED AND REPLACED BY AN RP FLEX PUMP WHICH WAS SUCCESSFULLY PLACED. THERE WAS NO HARM NOTED FROM ANY DELAY IN SUPPORT INITIATION. PATIENT HAS SURVIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979212 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  AN IMPELLA RP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL VEIN IN A 61-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF A PRIOR CORONARY ARTERY DISEASE (CAD), DIABETES, AND RENAL INSUFFICIENCY, PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE D SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. DURING THE PROCEDURE, THERE WAS CONTINUOUS OOZING AROUND THE SHEATH DESPITE MATTRESS SUTURES X 3. THE FIRST SUTURE WAS PLACED PRIOR TO THE BLEEDING, THE SECOND AND THIRD SUTURES WERE PLACED TO STOP THE BLEEDING. MANUAL PRESSURE WAS APPLIED FOR OVER 30 MINUTES. THE OOZING RESOLVED BY THE END OF THE PROCEDURE. THE PHYSICIAN WAS NOT CONCERNED AND THERE WAS NO DROP IN THE HEMOGLOBIN. HEPARIN WAS GIVEN PRIOR TO IMPELLA PLACEMENT. THE IMPELLA RP WAS REMOVED THE SAME DAY, WITH A BRIDGE TO AN IMPELLA RP FLEX. THE POST-PROCEDURE OUTCOME IS SURVIVED AT EXPLANT. THE IMPELLA RP FUNCTIONED AT P-7 AT 3.7L/MIN AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24680360 ↗
• InjuryMar 9, 2026Failure to Advance

  A 48-YEAR-OLD MALE WITH A HISTORY OF HEART FAILURE AND CARDIOGENIC SHOCK UNDERWENT IMPLANTATION OF AN IMPELLA 5.5 FOR LEFT-SIDED MECHANICAL CIRCULATORY SUPPORT. GIVEN THE EXTENT OF CARDIOGENIC SHOCK AND CONCERNS FOR RIGHT VENTRICULAR FAILURE, THE HEART TEAM PROCEEDED WITH AN ATTEMPT TO IMPLANT AN IMPELLA RP WITH SMARTASSIST (RPSA) VIA THE FEMORAL VEIN TO PROVIDE RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT. DURING THE PROCEDURE, THE TEAM WAS UNABLE TO ADVANCE THE IMPELLA RPSA CATHETER ACROSS THE RIGHT HEART AND INTO THE PULMONARY ARTERY. THE ATTEMPT WAS UNSUCCESSFUL DUE TO: SIGNIFICANT VESSEL TORTUOSITY, PREVENTING ADVANCEMENT TO APPROPRIATE PULMONARY ARTERY POSITION. GIVEN THE INABILITY TO SAFELY ADVANCE THE DEVICE, THE IMPELLA RP WAS REMOVED. THE HEART TEAM PLANNED TO PROCEED WITH PLACEMENT OF AN IMPELLA RP FLEX VIA AN ALTERNATIVE ACCESS SITE BETTER SUITED FOR THE PATIENT¿S ANATOMY REMAINED SUPPORTED BY IMPELLA 5.5 AFTER UNSUCCESSFUL RP IMPLANT. PLANS MADE TO PURSUE RP FLEX PLACEMENT FOR RIGHT-SIDED MECHANICAL CIRCULATORY SUPPORT VIA ALTERNATIVE ACCESS. NO HEMODYNAMIC INSTABILITY OR ADVERSE EVENTS REPORTED FROM THE UNSUCCESSFUL RPSA ATTEMPT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24547535 ↗
• MalfunctionMar 5, 2026Failure to Advance

  IMPLANTATION ABORTED DUE TO CONTRAINDICATION - PRESENCE OF THROMBUS IN RIGHT HEART. IMPELLA RP PROCEDURE ABORTED DUE TO CONTRAINDICATION - CONCERNS FOR THROMBUS IN THE RIGHT HEART. ALSO NOTED THAT PATIENT CONDITION IMPROVING WITH MANAGEMENT. NO DEVICE ISSUE FOUND, AND NO PATIENT INVOLVEMENT/CONSEQUENCE NOTED. THIS IS CONSIDERED A NON-REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521798 ↗
• MalfunctionMar 5, 2026Device Sensing Problem

  DURING IMPELLA RP SUPPORT, THE PLACEMENT SIGNAL UNRELIABLE ALARM WENT OFF AND THE PS WAVEFORM DISAPPEARED / WAS UNRELIABLE. THE PATIENT HAD A CHEST X-RAY DONE. A CLINICAL SUPPORT CALL WAS MADE AND TEAM WAS WALKED THROUGH HOW TO DISABLE THE ALARM AUDIO AND EXPLAINED THAT THE SENSOR DOES NOT IMPACT PUMP FUNCTION. THIS IS CONSIDERED A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521731 ↗
• MalfunctionMar 4, 2026Difficult to Insert

  A 58-YEAR-OLD FEMALE PRESENTED TO THE EMERGENCY ROOM WITH PALPITATIONS AND GROWING ANXIETY, QUICKLY DECOMPENSATING AND GOING INTO FULL HEART BLOCK. THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LABORATORY AND THE DECISION WAS MADE TO PLACE AN IMPELLA RP WITH SMART ASSIST. DURING PLACEMENT, THE PUMP COULD NOT BE PASSED THROUGH THE DISTAL INTRODUCER SHEATH. MULTIPLE ATTEMPTS WERE MADE BEFORE THE PROCEDURE WAS ABORTED AND THE DECISION MADE TO PLACE A VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION AND TRANSFER THE PATIENT TO A HIGHER CARE LEVEL OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507549 ↗
• MalfunctionFeb 6, 2026Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP WAS IMPLANTED VIA PERCUTANEOUS RIGHT FEMORAL VEIN FOR MECHANICAL CIRCULATORY SUPPORT. THE IMPELLA RP HAD A SENSOR MALFUNCTION. THE PROCEDURE WAS SUCCESSFUL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278549 ↗
• MalfunctionNov 14, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A PATIENT HAD SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION TO THE LEFT MAIN/LEFT ANTERIOR DESCENDING ARTERY. HOWEVER DURING THE COURSE OF THE PROCEDURE, IT WAS IDENTIFIED THAT THERE WAS A NEED FOR RIGHT VENTRICLE SUPPORT. THE DECISION FOR AN IMPELLA RP FLEX WAS MADE. HOWEVER, THEY WERE UNABLE TO PLACE THE IMPELLA RP FLEX DUE TO ANATOMY CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551952 ↗
• DeathSep 19, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP PUMP WAS IMPLANTED IN A PATIENT PRESENTED WITH HEART FAILURE FOR CIRCULATORY SUPPORT. DURING SUPPORT THE PUMP TRIGGERED INTERMITTENT 'PLACEMENT SIGNAL NOT RELIABLE' ALARMS. AT THE TIME OF THE NOTED CALL, THE DISPLAYED PLACEMENT SIGNAL WAS WITHIN NORMAL LIMITS AND POSITIONING WAS CONFIRMED VIA CHEST X-RAY. THE STAFF WAS ADVISED THAT THE SIGNAL WAS NOT REQUIRED FOR SUPPORT AND THE ALARM WAS SILENCED. THE FAMILY MADE THE DECISION TO WITHDRAW CARE AND THE PATIENT EXPIRED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 23102599 ↗
• DeathSep 19, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA CP PUMP WAS IMPLANTED TO SUPPORT A PATIENT WITH CARDIOGENIC SHOCK AND HEART FAILURE. WHILE ON SUPPORT, THERE WAS A PLACEMENT SIGNAL MALFUNCTION. CARDIOPULMONARY RESUSCITATION WAS PERFORMED PRIOR TO THE SIGNAL ISSUE. THERE WAS NO FURTHER INFORMATION PROVIDED. THE PATIENT EXPIRED WHILE ON SUPPORT.

  Patient problems: Cardiac Arrest; Unspecified Vascular Problem

  MAUDE report 23101890 ↗
• DeathSep 19, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT THE IMPELLA RP PLACEMENT SIGNAL NOT RELIABLE ALARM OCCURRED. X-RAY COMPLETED, WHICH CONFIRMED POSITION. THE PATIENT EXPIRED WHILE ON SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100142 ↗
• DeathSep 19, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP PUMP WAS IMPLANTED TO SUPPORT A PATIENT POST-OP TO CARDIOTHORACIC SURGERY. IT WAS REPORTED THAT THERE WAS AN UNRELIABLE PLACEMENT SIGNAL SENSOR DURING USE OF THE DEVICE. SUPPORT CONTINUED DESPITE THIS ISSUE. AS THERE WAS NO CONCERN FROM THE TEAM. NO FURTHER INFORMATION WAS PROVIDED. PATIENT EXPIRED WHILE ON SUPPORT.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 23097546 ↗
• DeathSep 19, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPLANTED IMPELLA RP PUMP TRIGGERED A PLACEMENT SIGNAL NOT RELIABLE ALARM DURING PATIENT SUPPORT. THE AUDIO ON THE ALARM WAS DISABLED, AND SUPPORT WITH THE PUMP CONTINUED. THE PATIENT EXPIRED WHILE ON SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097453 ↗
• MalfunctionSep 18, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA 5.5 AND IMPELLA RP PUMP WERE IMPLANTED AS BIPELLA SUPPORT IN A PATIENT FOR CIRCULATORY SUPPORT. WHILE ON BIPELLA SUPPORT, AFTER A COUGHING EVENT AND A TURN; A PATIENT SIGNAL NOT RELIABLE ALARM ON THE IMPELLA RP OCCURRED. FLOW STAYED THE SAME WITH NO CHANGE IN PATIENT OR PUMP PERFORMANCE. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092681 ↗
• MalfunctionSep 18, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP PUMP WAS IMPLANTED IN A PATIENT FOR CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THERE WAS A PLACEMENT SIGNAL UNRELIABLE ALARM. NO OTHER ISSUES WERE NOTED. THE PATIENT WAS SUCCESSFULLY WEANED FROM THE PUMP AND THE DEVICE EXPLANTED. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092667 ↗
• MalfunctionSep 18, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA CP PUMP WAS IMPLANTED IN A PATIENT FOR CIRCULATORY SUPPORT. THE CP WAS PLACED ALONG WITH AN IMPELLA RP FOR BIPELLA SUPPORT. THE RP HAD LOST PLACEMENT SIGNAL AFTER TWO DAYS OF SUPPORT. THE AUDIO WAS DISABLED. THE PUMP REMAINED ON FOR SUPPORT UNTIL WEANING AND EXPLANTATION. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092661 ↗
• MalfunctionSep 15, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP PUMP WAS IMPLANTED IN A PATIENT ADMITTED FOR MITRAL VALVE AND RIGHT VENTRICLE FAILURE. THE RP HAD LOST OPTICAL SIGNAL WITHIN HOURS OF PLACEMENT. THE PATIENT WAS ADDITIONALLY IMPLANTED WITH AN IMPELLA 5.5 PUMP. THE RP REMAINED ON FOR PATIENT SUPPORT UNTIL EXPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059326 ↗
• MalfunctionSep 15, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP PUMP WAS IMPLANTED IN A PATIENT FOR CIRCULATORY SUPPORT. DURING SUPPORT, THERE WAS LOSS OF PLACEMENT SIGNAL. THE TEAM DECIDED TO NOT REPLACE THE PUMP AND THE PATIENT REMAINED ON SUPPORT. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059304 ↗
• MalfunctionSep 8, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP PUMP WAS IMPLANTED TO SUPPORT A PATIENT EXPERIENCING ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. DURING SUPPORT, THE PLACEMENT SIGNAL WAS LOST. DESPITE THIS, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND CONTINUED TO RECEIVE EFFECTIVE SUPPORT FROM THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22997992 ↗
• MalfunctionSep 8, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP PUMP WAS IMPLANTED TO SUPPORT A PATIENT EXPERIENCING ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. DURING SUPPORT, THE PLACEMENT SIGNAL WAS LOST. DESPITE THIS, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND CONTINUED TO RECEIVE EFFECTIVE SUPPORT FROM THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22996889 ↗
• MalfunctionAug 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED THAT AN IMPELLA RP WAS UNABLE TO PASS THROUGH THE RIGHT VENTRICLE DUE TO THE PATIENT¿S ANATOMY. THE IMPELLA RP WAS EXCHANGED FOR AN IMPELLA RP FLEX SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841164 ↗
• MalfunctionJun 19, 2025Patient-Device Incompatibility; Device Sensing Problem; Patient-Device Incompatibility; Device Sensing Problem

  THE COMPLAINANT REPORTED A PATIENT WAS BEING IMPLANTED WITH AN IMPELLA RP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PUMP WAS REPLACED DUE TO DELIVERY ISSUES AND LOST OPTICAL SIGNAL. THE IMPELLA RP WAS REPLACED, AND SUPPORT PROCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292122 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT THE PATIENT EXPERIENCED NOTABLE BLEEDING FROM THEIR ACCESS SITE FOLLOWING THE IMPELLA RP IMPLANT. AN ADDITIONAL SUTURE WAS PLACED, AND MANUAL PRESSURE WAS HELD TO MANAGE THE CONDITION. THE FOLLOWING DAY THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION AND THE RP WAS EXPLANTED. THE PROCEDURAL OUTCOME WAS THE PATIENT SURVIVED SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22286951 ↗
• MalfunctionJun 9, 2025Patient-Device Incompatibility; Deformation Due to Compressive Stress; Patient-Device Incompatibility; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED A PATIENT WAS BEING IMPLANTED WITH AN IMPELLA RP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING IMPLANT, THE PHYSICIAN HAD NO ISSUES GAINING RIGHT FEMORAL ACCESS FOR IMPELLA RP INSERTION BUT OUTLET UNABLE TO CROSS PV. THE IMPELLA WAS PULLED BACK AND RE-ADVANCED, BUT CANNULA WITHIN RIGHT VENTRICLE BUCKLED OVER WIRE WHEN ADVANCED. AFTER MULTIPLE ATTEMPTS THE RP INSERTION WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169993 ↗
• MalfunctionMay 22, 2025Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA RP WAS ABORTED. THE PHYSICIAN COULD NOT ADVANCE THE IMPELLA RP DUE TO THE PATIENT'S ANATOMY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072191 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170011. One submission often covers many models, so check the product and lot details in each record.

• Z-3150-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Conn
• Z-3148-2026 · Aug 12, 2026 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella
• Z-3149-2026 · Aug 12, 2026 · Open, Classified
  Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella
• Z-2360-2026 · May 14, 2026 · Open, Classified
  Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; P
• Z-2211-2026 · Apr 20, 2026 · Open, Classified
  Automated Impella Controller (AIC); Product Code: 0042-0000-US;
• Z-1589-2026 · Feb 18, 2026 · Open, Classified
  Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5
• Z-1470-2026 · Jan 27, 2026 · Open, Classified
  Impella RP Flex with SmartAssist. Product Code: 1000323.
• Z-1471-2026 · Jan 27, 2026 · Open, Classified
  Impella RP. Product Code: 0046-0011.
• Z-0069-2026 · Oct 1, 2025 · Open, Classified
  Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product
• Z-0136-2026 · Sep 16, 2025 · Open, Classified
  Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella
• Z-2164-2025 · Jun 23, 2025 · Open, Classified
  Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella
• Z-0830-2025 · Dec 12, 2024 · Open, Classified
  Impella RP Flex with SmartAssist; Product Number: 1000323;
• Z-0636-2024 · Dec 6, 2023 · Open, Classified
  Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
• Z-3251-2026 · Feb 19, 2019 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impe
• Z-2238-2026 · Jan 17, 2011 · Open, Classified
  Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impel