| Class 1 Device Recall Impella CP with SmartAssist |  |
Date Initiated by Firm | May 31, 2024 |
Date Posted | July 17, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2319-2024 |
Recall Event ID |
94833 |
PMA Number | P140003 |
Product Classification |
Temporary non-roller type left heart support blood pump - Product Code OZD
|
Product | Impella 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 Contact | Customer 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 |
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 recall@abiomed.com 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. |
Total Product Life Cycle | TPLC 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 Database | PMAs with Product Code = OZD
|
|
|
|