FDA recall, , High risk
Abiomed Impella CP Sets and Low Profile Introducer Kits
Potential for thrombus formation during prolonged use of the introducer.
Summary by Recall Canary from the FDA notice
What happened
Abiomed, Inc., of Danvers, Massachusetts, recalled several Impella CP products because of the potential for thrombus formation during prolonged use of the introducer. The recall began May 22, 2026, and was added to the FDA's Enforcement Report on June 25, 2026.
The affected products include the Impella CP Set with SmartAssist (10th Generation) with affected 14Fr Low Profile Introducer Kits, the 14 Fr x 25 cm and 14 Fr x 13 cm Low Profile Introducer Kits for Impella CP, and the Impella CP Set with SmartAssist (10th Generation) with affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan.
Distribution was worldwide, including the states of Florida, Illinois, Minnesota, New Jersey, New York, and Virginia, and the country of Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Affected if its UDI-DI, lot code and product code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan.
- UDI-DI
- 813502013467
- Product code
- 1000542.
- Lot code
- 2041530
- 1000542
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits.
- UDI-DI
- 00813502013566
- 2026724558
- 2027818724
- 00813502013948
- 2026787668
- 2027818660
- Product code
- 1000413
- 1000834.
- Lot code
- 1000834
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
- UDI-DI
- 00813502013009
- Lot code
- 2038707
- 2045782
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
- UDI-DI
- 00813502012996
- Lot code
- 2038639
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Florida, Illinois, Minnesota, New Jersey, New York, Virginia and the country of Japan.
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99002
- Recall numbers
- Z-2599-2026 to Z-2602-2026
All recalls from Abiomed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
