Z-2319-2024Class I

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Name: Z-2319-2024 Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Creator: Abiomed, Inc.
Published: 2024-05-31
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2024-05-31 / Open, Classified

FDA source

Abiomed, Inc. began a recall of Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump on 2024-05-31. FDA classified it as Class I and gives the reason as "Nine (9) Impella CP pumps failed inspection and were inadvertently released". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2319-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-05-31
Posted: 2024-07-17
Recalling firm: Abiomed, Inc.
Product: Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: Nine (9) Impella CP pumps failed inspection and were inadvertently released.
FDA root cause: Release of Material/Component prior to receiving test results
Action: On 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 [email protected] or contact your local clinical field staff if you have questions or concerns regarding this notice.
Quantity in commerce: 9 units
Distribution: Domestic only: FL, MA, OH TX.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2319-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2319-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)