MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	0042-0000-US
Medical Device Problem Codes	False Alarm (1013); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An impella 5.5 was inserted surgically via right axillary/subclavian access site in 43-year-old male patient for cardiomyopathy.The patient¿s comorbidities were not reported.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage c identified as clinical evidence of hypoperfusion that initially requires pharmacological or mechanical support and decompensated the next day to (scai) shock stage d identified as clinical evidence of shock that worsens or fails to improve despite escalation therapies.The patient was on inotropes and vasopressors.On day 19 of impella support, the nurse reported bleeding and hematoma formation at the impella access site following transfer to the intensive care unit (icu).Heparin was held and manual pressure was applied, which reportedly controlled the bleeding.Information regarding anticoagulation monitoring, antithrombotic therapy, contributing patient conditions, blood product administration, and estimated blood loss was not provided.The patient injury was reported as access site bleeding and was attributed by the reporting facility to the impella therapy.On day 21 of support, it was reported that there were suction alarms while the device was operating at p-6 with flow of 3.7 l/min.Clinical review and troubleshooting were performed, including recommendation for echocardiographic evaluation and monitoring of hemodynamics and motor current trends.The results of the echocardiographic evaluations were not disclosed.The access site bleeding and formation of hematoma during impella 5.5 support is a recognized complication due to surgical arterial insertion and required anticoagulated therapy.The event was managed conservatively with heparin discontinuation and manual pressure.It is important to note that the impella device was providing support beyond the recommended 14 days of use.The causal relationship between the reported bleeding event and the impella system cannot be ruled out.
Event or Problem Description
Updated clinical narrative: additional information provided on 24sep2026, the suction was a false alarm.The aic was in need of recalibration and the alarms resolved after the waveforms were calibrated.The placement signal was off by more than 40 points.Previous clinical narrative an impella 5.5 was inserted surgically via right axillary/subclavian access site in 43-year-old male patient for cardiomyopathy.The patient¿s comorbidities were not reported.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage c identified as clinical evidence of hypoperfusion that initially requires pharmacological or mechanical support and decompensated the next day to (scai) shock stage d identified as clinical evidence of shock that worsens or fails to improve despite escalation therapies.The patient was on inotropes and vasopressors.On day 19 of impella support, the nurse reported bleeding and hematoma formation at the impella access site following transfer to the intensive care unit (icu).Heparin was held and manual pressure was applied, which reportedly controlled the bleeding.Information regarding anticoagulation monitoring, antithrombotic therapy, contributing patient conditions, blood product administration, and estimated blood loss was not provided.The patient injury was reported as access site bleeding and was attributed by the reporting facility to the impella therapy.On day 21 of support, it was reported that there were suction alarms while the device was operating at p-6 with flow of 3.7 l/min.Clinical review and troubleshooting were performed, including recommendation for echocardiographic evaluation and monitoring of hemodynamics and motor current trends.The results of the echocardiographic evaluations were not disclosed.The access site bleeding and formation of hematoma during impella 5.5 support is a recognized complication due to surgical arterial insertion and required anticoagulated therapy.The event was managed conservatively with heparin discontinuation and manual pressure.It is important to note that the impella device was providing support beyond the recommended 14 days of use.The causal relationship between the reported bleeding event and the impella system cannot be ruled out.
Additional Manufacturer Narrative
A5 and a6 are unknown.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc or its employees that the report constitutes an admission that the product, abiomed inc, or its employees, caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
B5, event description, has been updated.

• Brand Name: Impella
• Common Device Name: Temporary Non-Roller Type Left Heart Support Blood Pump
• Manufacturer (Section D): Abiomed, Inc. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50931766
• Report Number: 1220648-2026-13458
• Device Sequence Number: 10725378
• Product Code: OZD
• UDI-Device Identifier: 00813502010022
• UDI-Public: (01)00813502010022(11)110929(10)10903701
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0042-0000-US
• Device Lot Number: 10903701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 173 LB