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U.S. Department of Health and Human Services

Class 1 Device Recall Impella CP with SmartAssist

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 Class 1 Device Recall Impella CP with SmartAssistsee related information
Date Initiated by FirmMay 31, 2024
Date PostedJuly 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2319-2024
Recall Event ID 94833
PMA NumberP140003 
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
ProductImpella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Code Information Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.
Recalling Firm/
Manufacturer
Abiomed, Inc.
24 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information ContactCustomer Service
800-422-8666
Manufacturer Reason
for Recall
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
FDA Determined
Cause 2
Release of Material/Component prior to receiving test results
ActionOn May 31, 2024 consignees were contacted by phone with a script followed-up by sending URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters to consignees. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1.Examine your inventory immediately to determine if you have product subject to this recall(removal). QUARANTINE AND DO NOT USE THE SUBJECT PRODUCTS. 2.Your Abiomed Representatives have been provided instructions to support facilitation of locating, separating, and returning affected product for replacement. Work with your Abiomed Representative toreview, complete all fields, and sign the Business Response Form attached on page 4. IMPORTANT:The Business Response Form must be completed even if you have used any units of the subjectproduct on hand. 3.Forward this notice to any personnel in your facility who need to be informed. 4.If any of the product subject to this recall (removal) has been forwarded to another facility, contact thatfacility and provide a copy of this notice to the relevant personnel. 5.Post a copy of this notice in a visible area for awareness of this field safety notice. 6.As with any medical device, adverse reactions or quality problems experienced with the use of this productshould be reported to the FDA s MedWatch Adverse Event Reporting Program using the link below: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting- program/reporting-serious-problems-fda Please contact Abiomed Customer Service, 1-800-422-8666, option 2 (email recall@abiomed.com or contact your local clinical field staff if you have questions or concerns regarding this notice.
Quantity in Commerce9 units
DistributionDomestic only: FL, MA, OH TX.
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.
PMA DatabasePMAs with Product Code = OZD
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