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

FDA device recall Z-2319-2024 · posted 2024-07-17 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

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

Action taken

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 recall@abiomed.com or contact your local clinical field staff if you have questions or concerns regarding this notice.

Root cause

Release of Material/Component prior to receiving test results

Status

Open, Classified

Product code

OZD

Quantity affected

9 units

Distribution

Domestic only: FL, MA, OH TX.

Date initiated

2024-05-31

Date posted

2024-07-17

Location

Danvers, MA