Recall archive / FDA device enforcement
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and... — FDA record Z-2602-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 22, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
- Reason
- Potential for thrombus formation during prolonged use of the introducer.
- Classification
- Class I
- Recalling firm
- Abiomed, Inc.
- Quantity
- 7 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2602-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 1, 2026
- Recall initiation date
- May 22, 2026
- Center classification date
- Jun 25, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.