Impella catheters - Intravascular micro axial blood recall
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2)…
Why was Impella catheters - Intravascular micro axial blood recalled?
New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (1) 00813502011081 (2) 00813502011180 (3) 00813502011227 (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All products are affected by IFU Update ***Added 2/20/24*** (10) 813502010947 (11) 4260113630136 (12) 4260113630174 (13) 813502011197 (14) 813502010473 (15) 813502012453 (16) 813502012767 (17) 813502012927 (18) 813502012873 (19) 4260113630273 (20) 813502011821 (21) 813502011937 (22) 813502011951 (23) N/A (24) 4260113630242 (25) 813502011777 (26) 813502011265 (27) 4260113630280 (28) 813502011609 (29) 813502012200 (30) 813502011944 (31) 813502010046 (32) 813502010053 (33) 813502011630 (34) 813502010466
- Product
- Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2)…
- Recalling firm
- Abiomed, Inc.
- Quantity
- 92515
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
- Recall date
- February 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)