Impella RP Flex Introducer Kit 2000342Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00813502010411), received between Feb 13, 2026 and Aug 17, 2026 — classified as 3 deaths, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathAug 17, 2026Patient Device Interaction Problem

  Clinical Narrative:An Impella RP flex was inserted (site not reported) in a 75-year-old male patient presenting with Acute Myocardial Infarction/ Cardiogenic Shock. The patient¿s comorbidities were coronary artery, coagulopathy, liver dysfunction, and calcification. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D identified as clinical evidence of shock that worsens or fails to improve despite escalation therapies. The patient was on inotropes, vasopressors, and respiratory support.Baseline clinical parameters included a lactate level of 9.7 mmol/L and central venous pressure (CVP) of 5 mmHg. The Impella RP Flex was operating at P-8 and providing approximately 3.7 L/min of flow with a sodium bicarbonate in 5% dextrose purge solution. During support, the patient experienced bleeding at the venous access site around the sheath after insertion in the catheterization laboratory. The patient was receiving anticoagulant therapy with procedural IV heparin, had a reported ACT of >300 at the time of bleeding, and had contributing factors including coagulopathy, liver dysfunction, and calcification.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50279518 ↗
• InjuryJun 16, 2026Patient Device Interaction Problem

  AN IMPELLA RP FLEX DEVICE WAS INSERTED VIA THE RIGHT FEMORAL VENOUS APPROACH IN A 73-YEAR-OLD MALE PATIENT FOR THE INDICATION OF RIGHT VENTRICULAR FAILURE IN THE SETTING OF POST-OPERATIVE LEFT VENTRICULAR ASSIST DEVICE PLACEMENT. THE PATIENT¿S PAST MEDICAL HISTORY WAS SIGNIFICANT FOR RENAL INSUFFICIENCY REQUIRING DIALYSIS. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE E CARDIOGENIC SHOCK. DURING IMPELLA RP FLEX SUPPORT, IT WAS REPORTED THAT THE PATIENT HAD LOW PLATELET LEVELS, AND A CLINICAL DECISION WAS MADE TO UTILIZE A BICARBONATE-BASED PURGE SOLUTION WITHOUT SYSTEMIC ANTICOAGULATION. THE PURGE SOLUTION CONSISTED OF 5 PERCENT DEXTROSE IN WATER WITH 25 MILLIEQUIVALENTS PER LITER OF SODIUM BICARBONATE. INITIAL DEVICE FLOWS WERE APPROXIMATELY 3.0 LITERS PER MINUTE. OVERNIGHT, DEVICE FLOWS GRADUALLY DECREASED, ACCOMPANIED BY A DECREASE IN PURGE FLOW AND AN INCREASE IN PURGE PRESSURE. THERE WERE NO REPORTED KINKS OBSERVED IN THE PURGE LINE TUBING. THE ABSENCE OF SYSTEMIC ANTICOAGULATION WAS IDENTIFIED AS A CONTRIBUTING FACTOR IN THIS CLINICAL CONTEXT. IT WAS NOTED TPA WAS NOT ADDED

  Patient problems: Thromboembolism

  MAUDE report 25522149 ↗
• MalfunctionApr 30, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PEEL AWAY SHEETH WAS LEFT IN THE PATIENT DURING TRANSPORT OF THE PATIENT TO ANOTHER FACILITY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043091 ↗
• InjuryApr 28, 2026Failure to Advance

  THIS IMPELLA INTRODUCER DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA RP.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 25014765 ↗
• InjuryApr 15, 2026Fluid/Blood Leak

  AN IMPELLA RP FLEX DEVICE WAS INSERTED VIA THE RIGHT FEMORAL VEIN IN A 51-YEAR-OLD MALE PATIENT WITH A HISTORY OF DIABETES MELLITUS AND RENAL INSUFFICIENCY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE D. DURING THE PROCEDURE, BLEEDING WAS NOTED FROM THE HEMOSTATIC VALVE OF THE RP FLEX PEEL-AWAY SHEATH, REQUIRING THE OPENING OF A NEW INSERTION KIT. THE TEAM WAS CALLED TO DISCUSS LOW FLOWS, WITH ELEVATED PLACEMENT SIGNAL (PS) AND LOW ANTICOAGULATION LEVELS. HEPARIN WAS STARTED EARLIER. IT WAS DISCUSSED THAT FLOWS MAY BE FALSELY LOW DUE TO ELEVATED PS. NO HEMOLYSIS CHANGES WERE OBSERVED, BUT MONITORING FOR HEMOLYSIS WAS ONGOING. ON ROUNDS, PS REMAINED ELEVATED (137/84[103]) AND FLOWS WERE MUCH LOWER THAN EXPECTED (2.1/0.5 [1.5] AT P8). MOTOR CURRENT (MC) WAS 390/342 (365), CONSISTENT WITH THE SELECTED P LEVEL OF P8. HEPARIN INITIATION WAS DELAYED. POSSIBLE CLOT, SENSOR DRIFT, OR NEED FOR DEVICE REPLACEMENT WERE DISCUSSED AFTER ECHOCARDIOGRAPHY SHOWED A DECOMPRESSED RIGHT VENTRICLE, SUGGESTING ACTUAL FLOWS WERE HIGHER THAN CALCULATED. PHYSICIANS WERE CONSULTED ABOUT POSSIBLE CLOT IN THE DEVICE, AND FURTHER ECHO REVEALED A SEVERELY DILA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24884547 ↗
• DeathApr 7, 2026Difficult to Insert

  AN 81-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), CLASSIFIED AS SCAI STAGE E SHOCK, WAS IN THE CARDIAC CATHETERIZATION LABORATORY FOR MANAGEMENT OF BI-VENTRICULAR FAILURE. AN IMPELLA CP DEVICE WAS PLACED WITHOUT COMPLICATION TO PROVIDE LEFT-SIDED MECHANICAL CIRCULATORY SUPPORT, AND THERE WERE NO REPORTED ADVERSE EVENTS ASSOCIATED WITH THE IMPELLA CP. FOLLOWING IMPELLA CP PLACEMENT, THE CARE TEAM PROCEEDED WITH PLACEMENT OF AN IMPELLA RP FLEX DEVICE FOR RIGHT-SIDED SUPPORT. THE RIGHT INTERNAL JUGULAR (IJ) VEIN WAS PREPARED AND DILATED. DURING ATTEMPTED ADVANCEMENT OF A 23 FRENCH BY 11 CM PEEL-AWAY SHEATH OVER THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED, AND THE SHEATH WAS UNABLE TO BE ADVANCED BEYOND APPROXIMATELY 50 PERCENT, AT WHICH POINT IT REPEATEDLY BECAME STUCK BENEATH THE SKIN. DUE TO THE RESISTANCE ENCOUNTERED, THE PROVIDER ELECTED TO ABORT THE RIGHT IJ ACCESS ATTEMPT. THE CLINICAL TEAM SUBSEQUENTLY PROCEEDED WITH RIGHT FEMORAL VENOUS ACCESS FOR IMPELLA RP FLEX INSERTION. NO DIFFICULTY WAS ENCOUNTERED WITH ADVANCEMENT OF THE PEEL-AWAY SHEATH AT THE FEMORAL ACCESS SITE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801557 ↗
• MalfunctionMar 22, 2026Degraded; Material Integrity Problem

  AN IMPELLA RP WAS PLACED IN A SEVENTY-TWO-YEAR-OLD MALE PATIENT FOR TREATMENT OF AN ACUTE MYOCARDIAL INFARCTION WITH ASSOCIATED CARDIOGENIC SHOCK. DURING FEMORAL VENOUS ACCESS FOR PLACEMENT OF THE RIGHT-HEART PUMP, FLUOROSCOPY DEMONSTRATED THAT THE GUIDEWIRE WAS TWISTED. THE GUIDEWIRE WAS REMOVED ALONG WITH THE TWENTY-THREE FRENCH PEEL-AWAY SHEATH. IT WAS THEN NOTED THAT THE DISTAL PORTION OF THE PEEL-AWAY SHEATH WAS DAMAGED, WITH CLEAR EVIDENCE OF ABRASION. A SECOND INSERTION KIT WAS UTILIZED, AND THE PROCEDURE PROCEEDED. THIS CASE WILL BE CODED AS A VENOUS OCCLUSION WITH DEVICE REVISION OR REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24658995 ↗
• DeathMar 19, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 77-YEAR-OLD WOMAN WAS ADMITTED WITH A TYPE TWO AORTIC DISSECTION. SHE UNDERWENT A BENTALL PROCEDURE WITH PLACEMENT OF A MECHANICAL AORTIC VALVE AND CORONARY ARTERY BYPASS GRAFTS TO THE LEFT MAIN CORONARY ARTERY, WHICH WAS DISSECTED, AS WELL AS TO THE LEFT CIRCUMFLEX CORONARY ARTERY AND THE RIGHT CORONARY ARTERY, WHICH WERE ALSO DISSECTED. FOLLOWING SURGERY, THE PATIENT WAS SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP DUE TO DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS AND CONTINUED NEED FOR PHARMACOLOGIC CIRCULATORY SUPPORT. THE PATIENT EXPERIENCED RECURRENT HYPOTENSION, AND THE DECISION WAS MADE TO PROVIDE ADDITIONAL RIGHT VENTRICULAR SUPPORT. DURING ATTEMPTED DEVICE PLACEMENT, THE PATIENT REQUIRED DEFIBRILLATION AND DIRECT CARDIAC MASSAGE BY THE SURGEON ON THREE OCCASIONS PRIOR TO SUCCESSFUL PULMONARY ARTERY ACCESS AND RP FLEX PLACEMENT. DURING INSERTION OF THE SHEATH, A DISSECTION OF THE ILIAC VEIN OCCURRED. A SURGICAL CUTDOWN WAS PERFORMED, AND THE ILIAC VEIN INJURY WAS REPAIRED SUCCESSFULLY. ON (B)(6) 2025, CARE WAS WITHDRAWN. THE EVENT IS BEING CONSERVATIVELY REPORTED AS A PATIENT DEATH; HOWEVER, THE OUTCOME IS BELIEVED TO BE RELATED TO THE PATIENT¿S UND

  Patient problems: Vascular Dissection

  MAUDE report 24640651 ↗
• InjuryFeb 13, 2026Fluid/Blood Leak; Difficult or Delayed Separation

  AN IMPELLA RP FLEX WAS INSERTED VIA LEFT AXILLARY VEIN IN A 57 YEAR OLD FEMALE WHO WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT'S COMORBIDITIES WERE NOT INCLUDED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS SCAI STAGE D. DURING PLACEMENT, BLEEDING WAS OBSERVED FROM THE 23FR SHEATH VALVE AFTER THE DILATOR REMOVED. THE TEAM PEELED AWAY THE 23FR SHEATH AND SUPPORT PROCEEDED ON THE PUMP. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24333854 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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