Recall archive / FDA device enforcement
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; — FDA record Z-2963-2024
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 Aug 5, 2024. 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
- Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
- Reason
- A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- Classification
- Class II
- Recalling firm
- Abiomed, Inc.
- Quantity
- 2,916 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2963-2024
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 | Product Code: 0550-0008; UDI-DI: 00813502011531; Serial Numbers: 387019 388061 388062 388063 388064 388065 387273 388067 388068 387339 387340 387341 387342 387343 388071 388072 388073 388074 388075 388057 388058 388060 387319 387320 387321 387322 387323 383456 383457 383458 388084 383742 383731 384086 387304 387306 387307 387308 383455 383459 388081 388082 388083 388085 388076 388077 388078 388080 384031 384032 384033 384034 384035 383739 383741 383743 383729 383730 388311 388312 388301 388302 388307 383681 388605 388606 388607 388608 388286 388287 388288 388289 388295 388296 388297 388298 388299 388310 388313 388314 388290 388291 388293 388300 388304 388305 388306 388308 388309 389151 389152 388609 388624 388625 389117 389120 388619 388618 388617 388616 388615 388611 388612 388614 389116 389118 389119 389101 389102 389103 389104 389105 388626 388627 388628 388629 388630 388610 388613 389153 389154 389155 389320 389319 389318 389317 389316 389161 389163 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407751 407752 407753 407754 407755 407747 407748 407... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.
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
- Sep 11, 2024
- Recall initiation date
- Aug 5, 2024
- Center classification date
- Sep 4, 2024
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.