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U.S. Department of Health and Human Services

Class 1 Device Recall Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP

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 Class 1 Device Recall Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CPsee related information
Date Initiated by FirmMay 22, 2026
Date PostedJune 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2600-2026
Recall Event ID 99002
510(K)NumberK241708 
Product Classification Introducer, catheter - Product Code DYB
ProductAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Code Information Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
FEI Number 1220648
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information ContactMorgaine Johnson
978-646-1400
Manufacturer Reason
for Recall		Potential for thrombus formation during prolonged use of the introducer.
FDA Determined
Cause 2		Under Investigation by firm
ActionAbiomed notified consignees on about 05/22/2026, via letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were made aware of the issue and that if thrombus formation were to occur, the user may encounter difficulty aspirating the sheath sidearm or valve and may observe thrombus in the syringe or sidearm post aspiration or around the valve post CP pump removal. They were instructed to review inventory for affected units and quarantine them, arrange for their return using the provided shipment label from Sedgwick, and complete and return the provided business response form. Consignees were also instructed to forward the notification to anyone in the facility that needs to be informed, if any of the subject products have been forwarded to another facility, contact that facility and provide them with the notification, and to post a copy of the notification in a visible area for awareness.
Quantity in Commerce17 units
DistributionWorldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DYB
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