Abiomed, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0652-2024)

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 Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046

Product Classification:

Class II

Date Initiated: November 7, 2023

Date Posted: January 17, 2024

Recall Number: Z-0652-2024

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: 2551 units within set

Code Information:

UDI-DI: N/A

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