Impella 004334Recalls & reported problems

Summary

The FDA's MAUDE database contains 408 adverse event reports that list this exact device (DI 00813502011029), received between Feb 2, 2018 and Oct 27, 2025 — classified as 61 deaths, 212 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (67 reports).

3 FDA recall records name this device's identifier, 3 still open.

16 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. Feb 18, 2026Open, Classified

   Increased risk of purge leaks with Generation 1 purge cassettes.

   Z-1589-2026 · Root cause: Device Design · FDA record ↗

2. 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 ↗

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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 408 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Pumping Stopped; Pumping Stopped

  THE PUMP HAD A HIGH MOTOR CURRENT CAUSING THE PUMP TO STOP, ANOTHER DEVICE WAS USED, AND THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398638 ↗
• MalfunctionSep 19, 2025Device Sensing Problem; Device Sensing Problem

  THE COMPLAINANT REPORTED THE DEVICE'S PLACEMENT SIGNAL FAILING AFTER PATIENT WAS ROLLED DURING A PROCEDURE. PATIENT EXPIRED WHILE ON SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097363 ↗
• MalfunctionDec 17, 2024Failure to Sense; Failure to Sense

  THE COMPLAINANT REPORTED A PATIENT IN RIGHT VENTRICULAR FAILURE WAS IMPLANTED WITH AN IMPELLA RP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT HAD A PREVIOUS IMPELLA CP IMPLANTED AND ESCALATED TO AN IMPELLA 5.5 FOR INCREASED SUPPORT ON (B)(6) 2022. THE PATIENT WAS THEN BRIDGED TO A DURABLE LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2022. THE PATIENT WAS LATER FOUND TO BE IN RIGHT VENTRICULAR FAILURE AND THE DECISION WAS MADE TO PLACE THE IMPELLA RP. IT WAS REPORTED THAT DURING IMPELLA RP PLACEMENT, THERE WAS AN ALARM FOR ¿FLOW CALCULATION DISABLED¿ AND FAILED A MANUAL ZERO ATTEMPTED. THE INSERTION WAS ABORTED AND A NEW IMPELLA RP WAS SUCCESSFULLY PLACED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20956396 ↗
• DeathNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA RP FOR HEMODYNAMIC SUPPORT. WHILE ON SUPPORT IT WAS NOTED THE PATIENT WAS GIVEN LOTS OF VOLUME DUE TO BLEEDING COPIOUS AMOUNTS FROM CHEST TUBES. THE PATIENT RECEIVED OVER 63 BLOOD PRODUCTS. HEMODIALYSIS WAS ALSO SUCCESSFULLY INITIATED. HOWEVER, POST DIALYSIS THE PATIENT WAS MUCH WORSE. SPOUSE DECIDED TO WITHDRAW CARE, PATIENT EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 20760464 ↗
• DeathNov 22, 2024Malposition of Device; Malposition of Device

  THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT WAS ROLLED WHILE ATTEMPTING TO PLACE HYPOTHERMIA COOLING PADS ON THE PATIENT EARLY THIS MORNING. THE PATIENT WAS ROLLED AND THE IMPELLA RP WAS SUBSEQUENTLY PULLED FROM THE (PA) PULMONARY ARTERY. A CHEST X-RAY SHOWED THE OUTLET OF THE IMPELLA RP IN THE RA (RIGHT ATRIUM). THE PHYSICIAN DECIDED THAT WITH THE PATIENT'S CONDITION, THEY WOULD RATHER NOT MOVE THEM TO REPLACE THE PUMP. THE RP WAS PULLED AND A MATTRESS SUTURE WAS PLACED ON THE ACCESS SITE. IT WAS NOTED THAT THE PATIENT WAS WITHDRAWN FROM CARE AND EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759990 ↗
• MalfunctionNov 7, 2024Restricted Flow rate; Restricted Flow rate

  A NOTIFICATION WAS RECEIVED VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR (LOQI) IMPELLA REGISTRY REGARDING, THE COMPLAINANT REPORTED A 62-YEAR-OLD MALE PATIENT WITH RIGHT HEART FAILURE WAS IMPLANTED WITH AN IMPELLA RP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE IMPELLA RP WAS SUPPORTING FOR 2 WEEKS WHEN THE PUMP WAS EXPLANTED. THE TEAM REPORTED LOW FLOWS WITH POSSIBLE CLOT ENTRAINMENT. THERE WAS NO NOTED TREATMENT FOR THE LOW FLOWS DESPITE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630876 ↗
• MalfunctionOct 31, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT HAD AN IMPELLA RP THAT FAILED DELIVERY DESPITE ALL ATTEMPTS. THE PUMP WAS HUNG UP ON THE PREVIOUSLY PLACED EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULA. THE ATTEMPTED PLACEMENTS CAUSED THE RP TO KINK. IT WAS REMOVED AND NOT REPLACED. NO REPORTED HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577966 ↗
• MalfunctionOct 30, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A FAILED RP DELIVERY. SUPPORT WITH THIS DEVICE WAS ABORTED. THERE WAS NO HARM TO THE PATIENT RESULTING FROM THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575635 ↗
• DeathOct 30, 2024Pumping Stopped; Pumping Stopped

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IMPELLA RP PLACEMENT WAS ATTEMPTED. PT HAD A LARGE RV AND INSERTION WAS ATTEMPTED OVER A 0.35¿ GUIDEWIRE. GUIDEWIRE WAS REMOVED AND PUMP START ATTEMPTED. MOTOR CURRENT HIGH ALARM IMMEDIATELY OCCURRED, AND PUMP WAS UNABLE TO BE STARTED. THE RP WAS REMOVED AND A SECOND RP WAS ATTEMPTED TO BE PLACED HOWEVER DECISION WAS MADE TO STOP ALL EFFORTS DUE TO PROLONGED CODING TIME. THE ACT WAS UNKNOWN. ADDITIONAL INFORMATION NOTED THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575604 ↗
• DeathOct 30, 2024Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED THAT THEY ENCOUNTERED A PURGE PRESSURE HIGH/PURGE PRESSURE BLOCKED ALARM DURING IMPELLA SUPPORT. THE PURGE CASSETTE WAS REPLACED TO INITIALLY RESOLVE THE ALARMS; HOWEVER, THE ISSUE RETURNED A SHORT TIME AFTER. TWO MG TPA AND 50 CC OF WATER WERE HUNG AS PURGE FLUID AND THE ALARMS WERE AGAIN RESOLVED. ADDITIONAL INFORMATION NOTED THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20575547 ↗
• MalfunctionOct 30, 2024Failure to Advance; Failure to Advance

  THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA RP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, DEVICE EXPERIENCED DELIVERY ISSUES WHERE THE DEVICE COULD NOT PAST THE PULMONIC VALVE, DESPITE MULTIPLE ATTEMPTS. THE PUMP WAS REMOVED AND A SECOND RP PUMP WAS USED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575503 ↗
• MalfunctionOct 30, 2024Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA RP DEVICE AS ADDITIONAL BIPELLA SUPPORT FOR MECHANICAL CIRCULATORY SUPPORT. UPON INSERTION OF THE RP, THE PUMP INITIALLY DETECTED A PURGE PRESSURE HIGH ALARM FOLLOWED BY A PURGE SYSTEM BLOCKED ALARM. APPROPRIATE TROUBLE SHOOTING STEPS WERE PERFORMED (I.E. SWITCHING TO A NEW PURGE CASSETTE) HOWEVER THE PROBLEM PERSISTED INDICATING THE PURGE LUMEN OF THE RP WAS BLOCKED. THE PHYSICIAN INSISTED THE PUMP BE REPLACED SINCE THE PATIENT WAS UNSTABLE. THE REPLACEMENT IMPELLA RP PUMP WAS SUCCESSFULLY PLACED WITH THE SAME CASSETTE AND HAD NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575501 ↗
• DeathOct 30, 2024Decrease in Pressure; Decrease in Pressure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. FEW HOURS AFTER INSERTION LOW PURGE PRESSURE WAS OBSERVED. MULTIPLE ATTEMPTS WERE MADE BY ADJUSTING THE FLUID TO ADDRESS THE ISSUE, TO NO SUCCESS. THE TEAM DID NOT REPLACE THE PUMP DUE TO THE FAMILY WITHDREW CARE. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20575471 ↗
• DeathOct 30, 2024Pumping Stopped; Pumping Stopped

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. ADDITIONAL INFORMATION NOTED THE PATIENT EXPIRED. THE PUMP REPORTEDLY STOPPED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20575378 ↗
• DeathOct 30, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. AFTER MULTIPLE ATTEMPTS MADE TO ADVANCE THE RP, THE CANNULA WOULD BUCKLE AND WOULD NOT ADVANCE PAST THE TRICUSPID VALVE. MD NOTED A HEAVIER/STIFFER WIRE WOULD HELP TREMENDOUSLY. ADDITIONAL INFORMATION NOTED THAT CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20575376 ↗
• DeathOct 30, 2024Failure to Advance; Patient-Device Incompatibility; Failure to Advance; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. MULTIPLE RP CATHETERS KINKED DURING INSERTION AND FAILED DELIVERY. THE PROCEDURE OUTCOME IS THE PATIENT PASSED AWAY AND THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemodynamic instability

  MAUDE report 20575366 ↗
• DeathOct 30, 2024Positioning Failure; Positioning Failure

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA RP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT THE DEVICE LOST OPTIMAL POSITION. AFTER MULTIPLE ATTEMPTS WERE MADE TO REPOSITION THE DEVICE, THE DECISION WAS MADE TO REPLACE THE DEVICE WITH ANOTHER IMPELLA RP DEVICE. ADDITIONAL INFORMATION WAS PROVIDED THAT NOTED CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 20575365 ↗
• DeathOct 30, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE RP CATHETER KINKED AT MULTIPLE SITES WHEN INSERTING OVER 0.027. ADDITIONAL INFORMATION NOTED THAT THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575247 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA RP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT THE IMPELLA MOVED INTO THE RIGHT VENTRICLE AFTER THE PATIENT WAS TURNED. UPON REMOVAL OF THE RP, A LARGE CLOT WAS NOTED WHEN THE DEVICE WAS REMOVED FROM THE PEEL AWAY SHEATH. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20571065 ↗
• InjuryOct 30, 2024Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. T HE COMPLAINANT REPORTED THAT THE IMPLANTED IMPELLA RP PUMP DID NOT SIT WELL IN THE PATIENT AND SUBSEQUENTLY SHIFTED DURING SHEATH REMOVAL. AS A RESULT, THE DECISION WAS MADE TO REMOVE THE PUMP AND UTILIZE A NEW IMPELLA RP FOR ONGOING SUPPORT. UPON EXPLANT, IT WAS FURTHER NOTED THAT THERE WAS A CLOT WITHIN THE OUTLET OF THE PUMP. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20570944 ↗
• MalfunctionOct 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT KINKS WERE OBSERVED PREVENTING THE IMPELLA DEVICE TO DELIVER. IMPELLA SUPPORT WAS ABORTED WITHOUT ANY HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570880 ↗
• MalfunctionOct 30, 2024Pumping Stopped; Pumping Stopped

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THE PUMP THERE WERE HIGH PURGE PRESSURE ALARMS AND THE PUMP STOPPED AND WAS RESTARTED MULTIPLE TIMES. THE CASE WRAP UP INDICATES THE PATIENT REMAINED ON IMPELLA SUPPORT AND WAS SUCCESSFULLY WEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570754 ↗
• MalfunctionOct 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. THE IMPELLA PUMP WAS UNABLE TO BE DELIVERED DUE TO THE CATHETER SUBSEQUENTLY KINKED. THE IMPLANT RP WAS ABORTED AND ANOTHER RP WAS SUBSEQUENTLY PLACED FOR PATIENT SUPPORT. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570619 ↗
• MalfunctionOct 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE COMPLAINANT REPORTED A PATIENT OF UNKNOWN RACE WAS IMPLANTED WITH AN IMPELLA RP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT KINKS IN THE DRIVELINE WERE OBSERVED PREVENTING THE IMPELLA DEVICE TO ADVANCE. IMPELLA SUPPORT WAS ABORTED WITHOUT ANY HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570436 ↗
• MalfunctionOct 30, 2024Failure to Sense; Failure to Sense

  THE COMPLAINANT REPORTED A PLACEMENT SIGNAL NOT RELIABLE ALARM DURING USE OF THE DEVICE. A DECISION WAS MADE TO EXPLANT AND REPLACE THE IMPELLA. NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570280 ↗

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-1469-2026 · Jan 27, 2026 · Open, Classified
  Impella RP with SmartAssist. Product Code: 0046-0035.
• Z-1471-2026 · Jan 27, 2026 · Open, Classified
  Impella RP. Product Code: 0046-0011.
• Z-1470-2026 · Jan 27, 2026 · Open, Classified
  Impella RP Flex with SmartAssist. Product Code: 1000323.
• 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-0829-2025 · Dec 12, 2024 · Open, Classified
  Impella RP with SmartAssist; Product Number: 0046-0035;
• 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

…and 1 more.