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?
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
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 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All product IFUs include the Update ***Added February 2024*** (10) 813502010947 (12) 813502011821 (13) 813502011937 (15) N/A (16) 4260113630242 (17) 813502011777 (18) 813502011265 (19) 4260113630280 (20) 813502011609 (21) 813502012200 (22) 813502011944 (23) 4260113630136 (24) 813502010046 (25) 4260113630174 (26) 813502011197 (27) 813502010053 (28) 813502011630 (29) 813502010466 (30) 813502010473 (31) 813502012453 (32) 813502012767 (33) 813502012873 (34) 813502012873 ***Removed from scope March 15, 2024*** (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (11) 4260113630273 (14) 813502011951
- 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
- 91,914 (65,857 US; 26,075 OUS)
- 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 I
- Status
- Ongoing
- Agency
- FDA (device)