Abiomed, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0649-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body

Product Classification:

Class II

Date Initiated: November 7, 2023

Date Posted: January 17, 2024

Recall Number: Z-0649-2024

Event ID: 93501

Reason for Recall:

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.

Status: Ongoing

Product Quantity: 193 single units; 1034 units within kits

Code Information:

UDI-DI: 00885672009786

Distribution Pattern:

Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK

Voluntary or Mandated:

Voluntary: Firm initiated