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Impella Heart Pump recallZ-2319-2024 · Abiomed, Inc. · initiated May 31, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Nine (9) Impella CP pumps failed inspection and were inadvertently released.

FDA root cause category: Release of Material/Component prior to receiving test results

What the company is doing

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.

Recall details

Recall number
Z-2319-2024
Status
Open, Classified
Initiated by the company
May 31, 2024
Posted by the FDA
Jul 17, 2024
Recalling firm
Abiomed, Inc.
Quantity
9 units
Product code
OZD
FDA submissions
P140003
Distribution
Domestic only: FL, MA, OH TX.

Product description

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

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

11 devices cleared under P140003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page