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U.S. Department of Health and Human Services

Class 1 Device Recall ABIOMED Impella CP Set

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 Class 1 Device Recall ABIOMED Impella CP Setsee related information
Date Initiated by FirmJune 11, 2026
Date PostedJuly 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2689-2026
Recall Event ID 98893
510(K)NumberK192769 K201116 
Product Classification Introducer, catheter - Product Code DYB
ProductABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
Code Information Pump Set Code 0048-0014; Introducer Product Code 0052-3046. GTIN: 00813502012873, 00813502013344, 00813502013368, 04260113630280. All current batches in field.
FEI Number 1220648
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information ContactMorgaine Johnson
612-437-5734
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE RECALL (CORRECTION) notice dated 06/10/2026 was mailed to consignees. The notice directs consignees to maintain awareness of this recall among practitioners and use appropriate clinical awareness, monitoring, and patient support as needed. Further clinical direction is provided in the notice. The notification is to be forwarded to users and to facilities where product was further distributed. The notice should be visible for awareness. Consignees with any questions can contact OneMD-Field_Actions@its.jnj.com.
Quantity in Commerce35,430 units
DistributionWorldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
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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