Introducer Kit for Impella® 0052-3021 (UDI 00813502010558)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00813502010558), received between Jan 23, 2018 and May 20, 2025 — classified as 1 death, 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K122084); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Break; Break

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER (MATERIAL #0052-3021, LOT # DOR01986). THE COMPLAINANT REPORTED THAT DURING ATTEMPTED INSERTION, THE 23 FR INTRODUCER SHEATH CRACKED. THE DEVICE WAS REMOVED AND A 23 FR MEDTRONIC DILATOR WAS UTILIZED FOR THE PLANNED IMPELLA RP IMPLANT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE DEVICE WAS USED IN AN IMPELLA RP IMPLANT PROCEDURE. NO OTHER DEVICES USED IN THE PROCEDURE. NO MEDICAL INTERVENTION/ADDITIONAL SURGICAL PROCEDURE REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE BRAND. THE DEVICE WAS REMOVED WITHOUT ISSUE AND A MEDTRONIC SHEATH WAS UTILIZED FOR THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052760 ↗
• InjuryOct 28, 2024Material Integrity Problem; Material Integrity Problem

  WE HAVE BEEN NOTIFIED OF A COMPLAINT INVOLVING AN OSCOR 23 FR INTRODUCER (MATERIAL #0052-3021, LOT # DP-20999). THE COMPLAINANT REPORTED THAT COMPLICATIONS WERE ENCOUNTERED DURING ATTEMPTED DELIVERY OF AN IMPELLA RP PUMP. UPON INITIAL INSERTION, RESISTANCE WAS MET WHILE ATTEMPTING TO ADVANCE THE PUMP AND THE CANNULA KINKED. THE END OF THE PEEL AWAY SHEATH (23 FR INTRODUCER) SUBSEQUENTLY SPLIT, AND THE PUMP WAS PULLED BACK FOR A SECOND ATTEMPT. THE PATIENT BEGAN TO DECOMPENSATE AND BECAME HYPOTENSIVE. THE PUMP WAS AGAIN INSERTED, BUT THE IMPLANT WAS UNSUCCESSFUL, AND BOTH THE PUMP AND INTRODUCER HAD TO BE REMOVED. THE PATIENT WENT BRADYCARDIC AND CARDIOPULMONARY RESUSCITATION WAS INITIATED UNTIL THE PATIENT STABILIZED. A NEW PUMP AND INTRODUCER WERE THEN UTILIZED FOR A SUCCESSFUL IMPLANT. REGULATORY REPORTING REQUIRED FOR THE REPORT OF A DAMAGED INTRODUCER, DELIVERY ISSUES, AND PATIENT DECOMPENSATION DURING DELIVERY COMPLICATIONS RESULTING IN INTERVENTION. THE PATIENT WAS ADMITTED FOR ACUTE RESPIRATORY FAILURE, ARRYTHMIA, AND HYPOTENSION.CPR WAS INITIATED WHEN THE PATIENT BECAME BRADYCARDIC DURING DELAYED IMPLANT.THE PHYSICIAN BELIEVED THAT THE LEFT SIDED ACCESS COMBINED WITH THE PA

  Patient problems: Arrhythmia; Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 20544660 ↗
• InjuryMar 22, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A PROCEDURE FOR AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK AFTER INSERTION OF THE 23 FR OSCOR INTRODUCER, AN OPAQUE STRUCTURE WAS SEEN UNDER IMAGERY. WHEN THE INTRODUCER WAS ADVANCED, THE STRUCTURE MOVED WITH THE DEVICE. THE PROCEDURE WAS HALTED AND AN ANGIOGRAPHY WAS TAKEN, REVEALING A PEEL IN THE LOCK OF THE INTRODUCER - ONE PORTION WAS FOUND PERFORATING THE LEFT FEMORAL VEIN. THE PATIENT A (B)(6) FEMALE WAS THEN TRANSFERRED FOR ESCALATION OF CARE, WITH THE INTRODUCER STILL IN THE PATIENT'S BODY. ONCE PATIENT WAS TRANSFERRED, VASCULAR SURGERY WAS PERFORMED. THE PATIENT EXPIRED AFTER THERAPY WAS DISCONTINUED.

  Patient problems: Heart Failure/Congestive Heart Failure; Perforation of Vessels

  MAUDE report 13846572 ↗
• DeathJan 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK PROCEDURE AN IMPELLA RP PUMP'S FAILURE TO START PROMPTED THE REMOVAL AND ATTEMPTED DELIVERY OF A 2ND IMPELLA RP. DELIVERY OF THE 2ND RP FAILED AFTER MULTIPLE ATTEMPTS RESULTED IN THE INTRODUCER SPLITTING AT THE DISTAL TIP AND FOLDING ONTO ITSELF. THE PHYSICIAN WAS UNABLE TO STRAIGHTEN THE DEVICE. THE PATIENT'S FAMILY WITHDREW SUPPORT AND MADE THE PATIENT CMO (COMFORT MEASURES ONLY) MAKING THE PATIENT AS COMFORTABLE AS POSSIBLE WHILE THE NATURAL DYING PROCESS TAKES PLACE. PATIENT PASSED ON (B)(6) 2021 DUE TO CARDIOGENIC SHOCK SECONDARY TO STEMI. IT WAS SUSPECTED THAT EXCESSIVE MANIPULATION OF BOTH THE 1ST AND 2ND IMPELLA RP CAUSED THE DAMAGE TO THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306762 ↗
• InjuryNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT WAS PRESENTED TO THE PHYSICIAN, SUFFERING FROM A PE POST HIP SURGERY. IT WAS ATTEMPTED TO PLACE RP FOR SUPPORT. SIGNIFICANT BLEEDING AROUND SHEATH/ HEMATOMA NOTED AT SITE. CONTRAST INJECTED THROUGH R4 DIAGNOSTIC CATHETER INSERTED IN SHEATH. VESSEL TEAR/ DISSECTION NOTED ON FLUORO. PATIENT TRANSFERRED TO HYBRID ROOM. ECMO CANNULATION ON LEFT TO SUPPORT PATIENT. SURGICAL VESSEL REPAIR WITH PATCH FOR VENOUS TEAR. THE PATIENT WAS GIVEN 2 UNITS OF BLOOD. ANGIOGRAPHICALLY THE VESSEL DID NOT APPEAR CALCIFIED. THERE WAS SOME TORTUOSITY ON THE RIGHT VEIN. HEMOSTASIS WAS ACHIEVED WITH SURGICAL PATCH REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 12782603 ↗
• MalfunctionSep 3, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A COMPLAINT INVOLVING 2 OSCOR 23FR INTRODUCERS WHILE ATTEMPTING TO PASS THE IMPELLA RP THROUGH THE FIRST INTRODUCER, THE DEVICE KINKED WHICH PREVENTED THE IMPELLA FROM ADVANCING. THE INTRODUCER WAS REMOVED AND REPLACED WITH ANOTHER OSCOR 23FR INTRODUCER, HOWEVER, THIS DEVICE KINKED IN TWO LOCATIONS AND COULD NOT ADVANCE THE RP THROUGH THE END OF THE INTRODUCER, PAST THE DEVICE'S OUTFLOW CAGE. UPON REMOVAL OF THE RP DEVICE, THE TEARDROP DETACHED FROM THE IMPELLA AND REQUIRED A SURGICAL SNARE FOR REMOVAL. THE PATIENT WAS IN STABLE CONDITION, THEREFORE, THE PHYSICIAN PLANNED TO REST THE PATIENT AND POTENTIALLY TRY AGAIN WITH A NEW DEVICE IN THE MORNING. AFFECTED LOTS REPORTED: C1-14501 & CR-02070. REFERENCE MDR 1035166-2021-00098 FOR LOT NUMBER CR-02070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423768 ↗
• MalfunctionSep 3, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A COMPLAINT INVOLVING 2 OSCOR 23FR INTRODUCERS WHILE ATTEMPTING TO PASS THE IMPELLA RP THROUGH THE FIRST INTRODUCER, THE DEVICE KINKED WHICH PREVENTED THE IMPELLA FROM ADVANCING. THE INTRODUCER WAS REMOVED AND REPLACED WITH ANOTHER OSCOR 23FR INTRODUCER, HOWEVER, THIS DEVICE KINKED IN TWO LOCATIONS AND COULD NOT ADVANCE THE RP THROUGH THE END OF THE INTRODUCER, PAST THE DEVICE'S OUTFLOW CAGE. UPON REMOVAL OF THE RP DEVICE, THE TEARDROP DETACHED FROM THE IMPELLA AND REQUIRED A SURGICAL SNARE FOR REMOVAL. THE PATIENT WAS IN STABLE CONDITION, THEREFORE, THE PHYSICIAN PLANNED TO REST THE PATIENT AND POTENTIALLY TRY AGAIN WITH A NEW DEVICE IN THE MORNING. NO ADDITIONAL INFORMATION AVAILABLE. AFFECTED LOTS REPORTED: C1-14501 & CR-02070. REFERENCE MDR 1035166-2021-00096 FOR LOT NUMBER C1-14501.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423733 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED POST TRIPLE CORONARY ARTERY BYPASS AND HEMODYNAMICS WERE DECLINING. A SEVERE ST ELEVATION WAS NOTED, PROMPTING THE SELECTION OF THE IMPELLA RP FOR USE IN THIS PATIENT. DURING ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK PROCEDURE, 23 FR INTRODUCER WAS INSERTED IN THE PATIENT AND A KINK WAS IDENTIFIED MIDWAY UP THE DEVICE. THE IMPELLA RP WAS INSERTED THROUGH THE INTRODUCER, BUT COULD NOT SUCCESSFULLY CROSS INTO THE VENTRICLE FOR PROPER PLACEMENT. THE IMPELLA DEVICE WAS FOUND DAMAGED UPON REMOVAL AND THE PHYSICIAN DID NOT FEEL COMFORTABLE REMOVING THE INTRODUCER, SO VASCULAR SURGERY WAS CONSULTED. THE VASCULAR SURGEON REMOVED THE INTRODUCER AND CLOSED THE SITE, HOWEVER, A PERFORATION WAS FOUND IN THE PATIENT'S VEIN WAS FOUND. THE PERFORATION WAS ALLEGED TO HAVE BEEN CAUSED BY THE KINKED INTRODUCER. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO OTHER ADVERSE EVENT REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 11189294 ↗
• MalfunctionOct 15, 2020Deformation Due to Compressive Stress; No Apparent Adverse Event; Deformation Due to Compressive Stress; No Apparent Adverse Event

  THE PATIENT WAS PRESENTED TO THE PHYSICIAN WITH ACUTE MYOCARDIAL INFRACTION AND CARDIOGENIC SHOCK. MD ATTEMPTING TO PLACE RP, TRIED TO GET RP THRU SHEATH BUT THEN IT KINKED AND WOULDN'T GO FURTHER. NEW RP PULLED AND ATTEMPTED UNSUCCESSFULLY. PT CODED AND EXPIRED WHILE TRYING TO PLACE RP. THE REP DID RETURN IMPELLA PUMP PRODUCT, BUT NO SHEATH. CAUSE OF THE PATIENT DEATH IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiogenic Shock; Myocardial Infarction

  MAUDE report 10686905 ↗
• MalfunctionJul 28, 2020Crack; Crack

  IT WAS REPORTED THAT ON (B)(6) 2020, THERE WAS A 23 FR INTRODUCER SHEATH THAT CRACKED DURING A POST CARDIAC-CARDIOGENIC SHOCK (PCCS) RIGHT VENTRICLE (RV) FAILURE PROCEDURE. THE USER WAS PLACING THE SHEATH WHEN THE RP SHEATH VALVE BLEEDING WITH INSERTION OVER STIFF WIRE OCCURRED. THERE WAS A PROCEDURE DELAY AROUND 5 MINUTES. THE PATIENT EXPIRED DAYS LATER, HOWEVER, NOT RELATED TO THE SHEATH ISSUE.

  Patient problems: Death

  MAUDE report 10331773 ↗
• InjuryMar 20, 2020Break; Break

  IT WAS REPORTED DURING ACUTE MYOCARDIAL INFRACTION (AMI) AND CARDIOGENIC SHOCK (CGS) PROCEDURE WHILE INSERTING AN OSCOR 23FR INTRODUCER INTO THE ACCESS SITE, THE DISTAL END OF THE DEVICE SPLIT. THE INTRODUCER WAS REMOVED AND REPLACED WITH A NEW 23 FR INTRODUCER. NO FURTHER ISSUES WERE EXPERIENCED. DECISION MADE TO INSERT IMPELLA RP FOR RIGHT HEART SUPPORT. ADDITIONAL INFORMATION RECEIVED ON MARCH 4, 2020, WHEN THE SHEATH SPLIT IT TORE THE VEIN. THEY WERE ABLE TO STENT, NO SURGERY REQUIRED. NO SIGNIFICANT DELAY IN THERAPY. ADDITION INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cardiogenic Shock; Myocardial Infarction; Perforation of Vessels

  MAUDE report 9862240 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN FOR RIGHT VENTRICLE (RV) FAILURE. ACUTE MYOCARDIAL INFARCTION (AMI)/CARDIOGENIC SHOCK (CGS) PROCEDURE THERE WAS BLEEDING AT THE SHEATH INSERTION SITE WHILE USING A 23 FR INTRODUCER. FEMSTOP WAS APPLIED AFTER 30 PLUS MINUTES OF MANUAL PRESSURE. FEMSTOP WAS REMOVED BY CARDIOTHORACIC SURGERY (CT) SURGEON. CT SURGEON ADDED ADDITIONAL MATTRESS SUTURE, THEN RE-APPLIED FEMSTOP. PATIENT LOOSE 250CC OF BLOOD LOSS. INITIALLY THE SUTURES PLACED BY THE IC WERE PROBABLY SHALLOW TO THE SKIN. THE SURGICAL PA AND CT SURGEON WENT DEEPER WITH THEIR SUTURES. THEY DID AN ULTRASOUND TO CONFIRM THAT THERE WAS NOT A PERFORATION. FEMSTOP WAS IN PLACE FOR 6 HOURS AND HEMOSTASIS ACHIEVED. THE PATIENT WAS ON SUPPORT FOR FOUR (4) DAYS . THERE WAS NO PRODUCT PERFORMANCE ISSUE REPORTED. AS PER PHYSICIAN, SIZE DISCREPANCY BETWEEN THE RP PUMP AND THE REPO SHEATH WAS THE CAUSE FOR THE BLEED. NO OTHER INTERVENTION WAS NEEDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9813687 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED TO PHYSICIAN FOR CARDIOGENIC SHOCK. DURING ACCESS AT THE RIGHT FEMORAL VEIN FOR AN INSERTION OF THE IMPELLA RP PATIENT LOSS THE BLOOD WHILE PHYSICIAN REMOVING THE IMPELLA RP TO RE-POSITION IT. SINCE THE PATIENT STILL NEEDED THE RP A 23FR PEEL AWAY WAS TAKEN FROM THE OTHER RP KIT AT THE ACCOUNT. MD WAS THEN ABLE TO ADVANCE THE NEW SHEATH FOLLOWED BY THE RP CATHETER. PROCEDURE COMPLETED SUCCESSFULLY WITH ANOTHER OSCOR 23FR SHEATH. AMOUNT OF BLOOD LOSS IS UNKNOWN AND THERE WAS NO TRANSFUSION REQUIRED. PATIENT DIED ON 10/11/2019. CAUSE OF THE DEATH IS UNKNOWN. THE PRODUCT IS NOTED TO BE DISCARDED NO OTHER ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9371920 ↗
• MalfunctionDec 20, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS PER ADDITIONAL INFORMATION, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS DEVICE FAILURE. DETAILS ABOUT SECOND INTRODUCER IS UNKNOWN. THERE WAS DELAY TO REMOVAL AND ATTEMPTED PLACEMENT OF SECOND INTRODUCER. PRODUCT WAS DISCARDED.

  Patient problems: Cardiogenic Shock

  MAUDE report 8184777 ↗
• MalfunctionOct 19, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  AS PER ADDITIONAL INFORMATION, THERE WAS DIFFICULTY GETTING ACCESS TO THE ANATOMY WHEN PLACING IMPELLA AND FOR THAT REASON MULTIPLE INSERTIONS WERE MADE WITH VARIOUS WIRES.

  Patient problems: Death

  MAUDE report 7985526 ↗
• InjuryJun 8, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING A MEDICAL PROCEDURE, THE PATIENT WAS SLOWLY DECOMPENSATING, WITH RIGHT HEART FAILURE WHILE ON ECHO. AN IMPELLA RP WAS PLACED FOR SUPPORT FOR CARDIOMYOPATHY. ACCESS TO RFV; SOME DIFFICULTY PLACING SWAN INITIALLY INTO LPA BRANCH. RP ADVANCED OVER WIRE, BUT WOULD NOT MAKE TURN INTO PA, DESPITE ROTATIONS WITH PUSH-PULL TECHNIQUE. AN AMPLATZ 0.035 WIRE PLACED AS BUDDY WIRE, STILL NOT SUCCESSFUL IN TURNING INTO PA. ATTEMPTED TO ADVANCE FOR AT LEAST 35 MINUTES. HAD ISSUES WITH BLEEDING FROM THE PEEL-AWAY SHEATH VALVE; PATIENT REQUIRED ADMINISTRATION OF TWO UNITS OF BLOOD, D/T PRESSURES DROPPING, GTTS (DRIPS) INCREASED. DECISION MADE TO EXCHANGE SHEATH FOR ANOTHER RP PEEL-AWAY SHEATH. RP RE-ADVANCED THROUGH NEW SHEATH BUT STILL WOULD NOT MAKE TURN. AFTER ANOTHER 20 MINUTES THE SECOND PEEL-AWAY BEGAN TO EXHIBIT BLEEDING BACK THROUGH THE VALVE, SO DECISION MADE TO ABORT RP AND PLACE PATIENT ON TANDEM HEART VIA RIGHT IJ. BLEEDING WAS RESOLVED BY REMOVING SHEATH, SUTURE PLACED AND MANUAL PRESSURE HELD. PATIENT WAS REPORTED TO BE CRITICAL, TANDEM HEART PLACED AND PATIENT WAS SUCCESSFULLY SUPPORTED WITH THE TANDEM HEART.

  Patient problems: Blood Loss; Cardiomyopathy; Left Ventricular Failure

  MAUDE report 7584425 ↗
• MalfunctionApr 12, 2018Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK (AMI/CGS) PROCEDURE, THE 23FR INTRODUCER SHEATH FRACTURED INSIDE THE VESSEL. IT WAS DURING INSERTION OF THE IMPELLA RP PUMP THAT IT WAS NOTED THE 23F INTRODUCER SHEATH HAD FRACTURED WHILE INSIDE THE VESSEL. THE FRACTURED SHEATH WAS REMOVED, A NEW 23F SHEATH WAS OBTAINED AND THE PROCEDURE WAS COMPLETED, THE IMPELLA RP WAS DELIVERED. THIS (B)(6) MALE PATIENT HAS HISTORY OF RUNS OF VENTRICULAR TACHYCARDIA AND THE PULMONARY ARTERY PULSATILITY INDEX WAS TRENDING DOWN. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT NOR ANY EXTENDED HOSPITALIZATION. NO FURTHER PATIENT OR INCIDENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7425373 ↗
• InjuryJan 23, 2018Kinked; Split; Kinked; Split

  THE CUSTOMER REPORTED THIS INTRODUCER WAS BEING USED FOR INSERTION OF THE IMPELLA RP AT THE FEMORAL VEIN. THE PATIENT WAS PRESENTED TO THE CATH LAB FOR RP PLACEMENT POST CORONARY ARTERY BYPASS GRAFT (CABG). WHEN ATTEMPTING TO PLACE THE 23FR INTRODUCER FOR RP IMPLANT, THE INTRODUCER WAS SEEN TO BE COMPROMISED AT INSERTION AND KINKED/SPLIT. THERE WAS AN ILIAC VEIN PERFORATION, WHICH DID REQUIRE STENTING AND BETWEEN 4-6 UNITS OF BLOOD PRODUCT REPLACEMENT. THE DEVICES INVOLVED WITH THIS PROCEDURE WERE USED IN THE FOLLOWING SEQUENCE: 23FR INTRODUCER, FOLLOWED BY IMPELLA RP AND A STENT OF UNKNOWN MANUFACTURER. THE OUTCOME OF THE PATIENT IS STABLE.

  Patient problems: Blood Loss; Perforation

  MAUDE report 7213306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

• Z-2678-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
• Z-2680-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
• Z-2679-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
• Z-1467-2021 · Feb 22, 2021 · Terminated
  AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheter