Food, drugs, devices › Abiomed, Inc.
Device recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product C
FDA enforcement event 99002 is a device recall by Abiomed, Inc. of Danvers, MA, initiated 22 May 2026 and classified Class I, with 4 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 12% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Abiomed, Inc. has 30 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Abiomed, Inc., Danvers, MA.
Reason for recall
"Potential for thrombus formation during prolonged use of the introducer."
Distribution
"Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2599-2026 | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434. | 3 units | Class I | Ongoing | 1 Jul 2026 |
| Z-2600-2026 | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435. | 17 units | Class I | Ongoing | 1 Jul 2026 |
| Z-2601-2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. | 168 units | Class I | Ongoing | 1 Jul 2026 |
| Z-2602-2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542. | 7 units | Class I | Ongoing | 1 Jul 2026 |
Context
Other enforcement events for Abiomed, Inc.
All 30 events for Abiomed, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for thrombus formation during prolonged use of the introducer."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.