FDA recall Z-2601-2026

Abiomed, Inc. · Class I · device

Product

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

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.

Key facts

Status
Ongoing
Initiation date
2026-05-22
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2601-2026