Introducer Kit for ImpellaRecalls & reported problems across all models

We found 11 models of Introducer Kit for Impella by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 1,326 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2017 and Sep 30, 2026 — classified as 234 deaths, 697 injuries, 395 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (76 reports).

9 FDA recall records name at least one of these models by its device identifier, 9 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Introducer Kit for Impella recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 11, 2026Open, Classified

   A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

   Z-2690-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 10, 2026Open, Classified

   Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

   Z-2680-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. Jun 10, 2026Open, Classified

   Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

   Z-2679-2026 · Root cause: Device Design · Recall details · FDA record ↗

4. Jun 10, 2026Open, Classified

   Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

   Z-2678-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

5. Aug 5, 2024Open, Classified

   A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

   Z-2955-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. 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 · Recall details · FDA record ↗

7. 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 · Recall details · FDA record ↗

8. Nov 7, 2023Open, Classified

   Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.

   Z-0649-2024 · Root cause: Process control · Recall details · FDA record ↗

9. Nov 7, 2023Open, Classified

   Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

   Z-0646-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported Introducer Kit for Impella problems

Introducer Kit for Impella models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Introducer Kit for Impella® 0052-3006

  pacemaker lead Adaptor
  4 recalls223 deaths1,184 reports
• Introducer Kit for Impella® 0052-3006

  INTRODUCER, CATHETER
  2 recalls4 deaths33 reports
• Introducer Kit for Impella® 0052-3021

  INTRODUCER, CATHETER
  2 recalls17 reports
• Introducer Kit for Impella® 0052-3025

  INTRODUCER, CATHETER
  1 recall1 death32 reports
• Introducer Kit for Impella® 0052-3025

  INTRODUCER, CATHETER
  1 recall10 reports
• Introducer Kit for Impella® 0052-3000

  pacemaker lead Adaptor
  2 deaths19 reports
• Introducer Kit for Impella® 0052-3021

  INTRODUCER, CATHETER
  1 death18 reports
• Introducer Kit for Impella® 0052-3001

  pacemaker lead Adaptor
  2 deaths6 reports
• Introducer Kit for Impella® 0052-3014

  INTRODUCER, CATHETER
  1 death3 reports
• Introducer Kit for Impella® 0052-3015

  INTRODUCER, CATHETER
  2 reports
• Introducer Kit for Impella® 0052-3000

  INTRODUCER, CATHETER
  2 reports

Recent Introducer Kit for Impella adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Contamination

  It was reported that the affected component was the introducer kit. The time of occurrence was unknown. This issue was identified during use of the Impella CP pump. A 16 Fr. sheath was used. There was no patient impact. During use of the Impella CP, multiple water droplets were observed around the dilator coated with silicone lubricant within the introducer kit. Water droplets were also noted on the outside of the tube covering the dilator. As a 16 Fr sheath is routinely used at the facility, there was no impact on the procedure. The pump, purge cassette, and guidewire were all used without issue. The product had been stored in the catheterization laboratory under the facility's standard storage conditions. Additional information was provided which indicated that the hospital indicated that the bag had a sticky residue on it. The device was examined and found it to be slightly sticky as well. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948616 ↗
• InjurySep 29, 2026Failure to Advance; Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938430 ↗
• InjuryAug 26, 2026Restricted Flow rate

  An Impella CP was inserted via the left femoral artery in a 56-year-old male patient undergoing planned coronary artery bypass surgery. The patient's comorbidity was known coronary artery disease. The SCAI shock stage prior to support initiation was not documented. Prior to Impella support, the patient was receiving respiratory support.Two days after implantation, the patient's condition deteriorated with concerns for right heart failure. Extracorporeal membrane oxygenation (ECMO) was initiated as the primary support modality, and inotropic and vasopressor therapy were added. The Impella CP remained in place to provide left ventricular unloading and venting during ECMO support.On day 3 of support, the Impella CP experienced a sudden reduction in flow associated with suction alarms. Troubleshooting measures included reduction of the pump performance level, assessment of device position, and evaluation of volume status, all of which were reported to be appropriate. Due to the low-flow event and ongoing need for escalated circulatory support, the decision was made to explant the Impella CP and upgrade support to an Impella 5.5 device.At the time of explant, clot material was observed

  Patient problems: Thromboembolism

  MAUDE report 50457368 ↗
• InjuryAug 26, 2026Difficult to Remove

  An Impella CP was implanted via the right femoral artery in a 70-year-old male patient for pre-operative ventricular support prior to a planned ventricular septal perforation (VSP) closure. Prior to Impella support, the patient was classified as Society for Cardiovascular Angiography and Intervention (SCAI) Stage B shock, indicating hemodynamic instability. The patient was receiving ventilatory support prior to implantation. The patient's past medical history was not reported.The Impella CP provided hemodynamic support and functioned within expected operating parameters at P-5 with reported flows of approximately 2.6 L/min utilizing a D5W Sodium Bicarbonate purge solution.After approximately four days of support, an attempt was made to surgically remove the Impella CP in the intensive care unit (ICU); however, significant resistance was encountered during extraction. Fluoroscopic evaluation demonstrated that the pigtail tip remained stationary, raising concern for entanglement with an intracardiac structure. The patient was transferred to a hybrid operating room, where a second removal attempt under fluoroscopic guidance was performed; however, the device remained unable to be extr

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456035 ↗
• MalfunctionAug 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173572 ↗
• InjuryAug 3, 2026Patient Device Interaction Problem

  Clinical Narrative Impella CP was inserted via left femoral artery in a 80-year-old male patient presenting with Acute Myocardial Infarction and Cardiogenic Shock. The patient¿s comorbidities were known peripheral arterial disease at the superficial femoral artery. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage E. Prior to the Impella CP placement the patient was supported by Extra Corporeal Membrane Oxygenation (ECMO).While on support the the device functioned as expected, Performance Level P-8 with 3.1L/min flow with 5% Dextrose in water with sodium bicarbonate in the purge solution.While on support the team did add inotropes and vasopressors due to patient condition. The Impella accessed limb showed signs of ischemia. The leg had become pale and discolored. This prompted the explant of the pump after just 1 day of support. The Physician placed a new second Impella CP at the right subclavian artery and performed endovascular thrombectomy (EVT) to restore limb flow.The patient's limb ischemia occurred after the pump delivery to the femoral artery which was noted to be narrow. The underlyin

  Patient problems: Ischemia

  MAUDE report 50122855 ↗
• InjuryAug 3, 2026Malposition of Device; Patient Device Interaction Problem

  US Updated clinical narrative: Additional information provided on 31JUL2026 The device was explanted on (b)(6)2026Prior US Clinical Narrative:Impella CP was percutaneously inserted via left femoral artery access site in a 77-year-old male patient presenting with cardiomyopathy and suspected myocarditis. The patient¿s comorbidities were not reported. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D. The patient was medically supported by inotropes, vasopressors and was concurrently on ECMO.During Impella support, there were concerns of hemolysis identified by hematuria. Imaging was utilized to assess pump position, and improper device positioning was initially suspected; however, despite position adjustment, hemolysis persisted without immediate improvement. No anatomical cardiac abnormalities were reported, and there was no reported contact between the pump and mitral valve structures. Haptoglobin therapy was administered, and following ECMO weaning and reduction of Impella support level from Performance (P) level P-7 to P-4, the hemolysis showed signs of improvement.The hemolysis was most

  Patient problems: Hemolysis

  MAUDE report 50114548 ↗
• InjuryJul 27, 2026Restricted Flow rate; Increase in Pressure; Deformation Due to Compressive Stress

  Clinical Narrative:An Impella CP device was inserted into the right femoral artery in a 56-year-old male patient presenting in acute myocardial infarction (AMI) and cardiogenic shock (CGS), prior to initiation of support. The patient's comorbidities and Society for Cardiovascular Angiography & Intervention (SCAI) shock stage are unknown.While the patient was in the intensive care unit (ICU), the right leg was immobilized with a knee extension brace to prevent flexion of the groin and knee. On the eighth day of support, it was noted that the purge sidearm was completely separated, cutting off the supply of purge fluid. due to the patient bending the knee. The Impella was removed and replaced with an intra-aortic balloon pump (IABP).The post-procedure outcome is survived at explant. While on support, the Impella functioned as intended at performance level P-4 at 2.2L/min with D5W Heparin in the purge solution.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034399 ↗
• DeathJun 1, 2026Fluid/Blood Leak

  CLINICAL NARRATIVE AN IMPELLA 5.5 WAS INSERTED VIA THE RIGHT AXILLARY ARTERY VIA THE ABIOMED PROVIDED INTRODUCER KIT, TO SUPPORT THE 73 YEAR OLD MALE WITH ACUTE DECOMPENSATED CHRONIC CARDIOMYOPATHY, PRESENTING IN SCAI STAGE E SHOCK. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE SURGEON PLACED THE PUMP AND FELT THAT THE GRAFT LOCK CLIPS WERE NOT TIGHT ENOUGH AND LESS TIGHT THAN USUAL, WHICH LEAD TO BLOOD LOSS/LEAKING AROUND THE SHEATH AND GRAFT. THE TEAM REPLACED THE SHEATH WITH A NEW SHEATH AND SUPPORT PROCEEDED. THERE WAS NO NOTED HARM FROM THE PRODUCT REPLACEMENT. THE TEAM DID NOTE THAT ALL BEST PRACTICES FOR ACCESS WERE FOLLOWED. THE SUPPORT WAS ONGOING FOR OVER 5 DAYS AND THEN THE TEAM MADE DECISION TO WITHDRAW CARE. WHILE ON THE SUPPORT THE 5.5 DEVICE FUNCTIONED AS INTENDED AT P-8 AT 4.7L/MIN WITH D5W SODIUM BICARBONATE IN THE PURGE SOLUTION. THERE WAS NO ALLEGATION THAT THE SHEATH LEAK CONTRIBUTED TO THE PATIENT OUTCOME. THE DEATH IS BEING CONSERVATIVELY REPORTED; HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE PATIENT¿S DEATH IS NOT ATTRIBUTED TO THE EVENT DESCRIBE AND IS MORE LIKELY ATTRIBUTABLE TO THE REPORTED CARDIOMYOPATHY, PRESENTING IN SCAI STAGE E.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25349032 ↗
• MalfunctionMay 28, 2026Crack; Fluid/Blood Leak; Patient Device Interaction Problem

  THE COMPLAINANT REPORTED THAT THE CARDIOVASCULAR SURGEON (CVS) PLACED 23F INTRODUCER (FROM AXILLARY KIT) INTO THE GRAFT AND PLACED 2 GRAFT LOCKS. CVS THEN CUT SOME OF THE GRAFT LENGTH AT THIS TIME. CVS THEN GAINED LV ACCESS AND EXCHANGED THE J-WIRE FOR THE 0.18 ABIOMED WIRE. CVS THEN PROCEEDED TO PLACE IMPELLA 5.5, BUT THE CVS DID NOT APPROVE THE LENGTH OF THE GRAFT. SOFT CLAMPS WERE PLACED OVER THE GRAFT AND THE CVS REMOVED THE PEEL AWAY SHEATH FROM THE GRAFT OVER THE 0.018 WIRE AND THEN CUT THE GRAFT DOWN TO HIS LIKING. THE CVS THEN ADVANCED THE PEEL AWAY SHEATH BACK INTO THE AXILLARY GRAFT. CVS THEN ADVANCED THE IMPELLA 5.5 TO THE HEMOSTATIC VALVE AND INITIALLY EXPERIENCED DIFFICULTY ADVANCING THROUGH THE HEMOSTATIC VALVE BUT DID ADVANCE THROUGH COMPLETELY. THE SOFT SOFT CLAMP WAS THEN REMOVED, AND BLEEDING WAS NOTED AT THE PEEL AWAY SHEATH / HEMOSTATIC VALVE AND APPEARS CRACKED. IT WAS ALSO NOTED THAT THE WIRE WAS SLIGHTLY ABOVE THE MIDDLE OF THE HEMOSTATIC VALVE. CVS THEN REMOVED THE IMPELLA 5.5 FROM THE GRAFT AND REAPPLIED THE SOFT CLAMPS. THE CVS THEN OPTED TO REMOVE THE 23 FRENCH PEEL AWAY SHEATH AND EXCHANGE IT FOR A NEW ONE. A NEW AXILLARY KIT WAS OPENED, AND NEW PEEL AWA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25323927 ↗
• InjuryMay 18, 2026Fluid/Blood Leak; Patient Device Interaction Problem

  CLINICAL NARRATIVE: AN IMPELLA 5.5 WAS INSERTED VIA THE DIRECT SURGICAL ACCESS AT THE AORTA FOR THE PATIENT ADMITTED IN WITH PLAN FOR A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY DUE TO MULTIVESSEL CORONARY ARTERY DISEASE. THE PATIENT PRESENTED AT SCAI STAGE E SHOCK AT THE ELECTIVE PUMP IMPLANT. THE OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE 5.5 WAS PLACED VIA THE 23FR SHEATH AND 10MM GELWEAVE GRAFT. THE INSTRUCTIONS FOR USE SPEAK TO A 10MM X20 HEMASHIELD PLATINUM GRAFT. AFTER THE GRAFT WAS ACCESSED WITH THE 23FR INTRODUCER THE TEAM APPLIED THE GRAFT LOCKS, HOWEVER THERE WAS PERSISTENT BLEEDING OUTSIDE THE DISTAL END OF THE GRAFT. TO REMEDY THE BLEED THEY HAD TO PLACE 3 HEAVY SILK TIES TO ACHIEVE HEMOSTASIS. THE TROUBLESHOOTING WAS NECESSARY DESPITE THE TEAM USING ALL BEST PRACTICES AT THE ACCESS. BLEEDING IN THIS CLINICAL CONTEXT IS A KNOWN AND EXPECTED RISK ASSOCIATED WITH IMPELLA 5.5 SUPPORT, PARTICULARLY IN THE SETTING OF MAJOR CARDIAC SURGERY AND DIRECT SURGICAL AORTIC ACCESS. THE PUMP REMAINED ON FOR SUPPORT TO DATE TILL WEAN AND EXPLANT. NO OTHER INTERVENTION, SUCH AS BLOOD PRODUCT DELIVERY, HAD BEEN DEEMED NECESSARY. THE PATIENT SURVIVES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25199812 ↗
• MalfunctionMay 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT IMPLANTATION OF AN IMPELLA CP WAS ABORTED DUE TO PATIENT ANATOMY. THE PUMP COULD NOT ADVANCE PAST THE PATIENT'S TORTUOUS AORTIC ARCH. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096399 ↗
• MalfunctionMay 6, 2026Deformation Due to Compressive Stress

  THE COMPLAINANT REPORTED THAT A PATIENT WAS TO BE IMPLANTED WITH AN IMPELLA CP VIA PERCUTANEOUS RIGHT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. SEVERE TORTUOSITY MADE THE IMPELLA INSERTION DIFFICULT. THE INSERTION WAS ABANDONED. THE PATIENT'S OUTCOME IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095323 ↗
• MalfunctionMay 1, 2026Break

  CUSTOMER REPORTED THAT THE CLEAR PLASTIC RING ON THE HUB OF THE 14FR DILATOR HAS BECOME SEPARATED FROM THE DILATOR DURING DILATOR REMOVAL FROM THE PEEL AWAY SHEATH. THE PHYSICIAN HAS THEN REMOVED THE PEEL AWAY SHEATH AT THE COMPLETION OF THE IMPLANT WITH THE CLEAR RING STILL ATTACHED. SHE HAS THEN SEPARATED THE TWO IN ORDER TO PEEL AWAY THE SHEATH BUT THE CLEAR RING HAS THEN BEEN LEFT OVER THE IMPELLA CATHETER ITSELF AND NEEDED TO BE CUT OFF. UNCLEAR IF IT WAS PHYSICALLY BROKEN DURING IMPLANT OR MANUFACTURING ERROR. THERE WAS NO PATIENT HARM AND THE PATIENT REMAINS ON SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059844 ↗
• InjuryApr 29, 2026Patient Device Interaction Problem

  A 56-YEAR-OLD MALE UNDERWENT HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI) WITH IMPELLA CP SUPPORT FOR A PRE-SUPPORT CLINICAL STATE CONSISTENT WITH SCAI SHOCK STAGE D. THE IMPELLA CP WAS PERCUTANEOUSLY IMPLANTED VIA FEMORAL ARTERIAL ACCESS. DURING THE PROCEDURE, THE PATIENT WAS ON ANTICOAGULATION THERAPY WITH HEPARIN BOLUSES; DETAILS REGARDING ANTICOAGULATION MONITORING WERE UNKNOWN. WHILE THE INTRODUCER SHEATH REMAINED IN PLACE, ACCESS SITE BLEEDING MANIFESTED AS A HEMATOMA AT THE FEMORAL ARTERIOTOMY/VESSEL. DUE TO THE ACCESS SITE BLEEDING, THE IMPELLA DEVICE AND INTRODUCER WERE REMOVED, AND HEMOSTASIS WAS ACHIEVED FOLLOWING DEVICE REMOVAL. THE ESTIMATED BLOOD LOSS WAS UNKNOWN. THE PATIENT SURVIVED THE EVENT AND WAS STABLE AT EXPLANT. BLEEDING IS CONSISTENT WITH ACCESS SITE COMPLICATIONS AS A RESULT OF LARGE BORE FEMORAL PROCEDURES AND THE ANTICOAGULATION AND PURGE REQUIREMENTS ASSOCIATED WITH IMPELLA SUPPORT. IT IS UNKNOWN WHETHER RECOMMENDED BEST PRACTICES FOR ACCESS MANAGEMENT WERE FOLLOWED TO MITIGATE THE RISK OF BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25035623 ↗

Other Oscor Inc. products

• Guidestar Steerable Guiding Sheath2 models · 103 reports · 1 recall
• SafeSheath II14 models · 146 reports
• Destino Twist Steerable Guiding Sheath19 models · 45 reports · 1 recall
• SafeSheath Ultra Lite3 models · 24 reports · 1 recall
• Occlutech Delivery Set III10 models · 39 reports
• TourGuide Steerable Sheath9 models · 37 reports
• DiRex Steerable Sheath7 models · 22 reports
• Lead Adaptor3 models · 20 reports