Impella 0052-0038Recalls & reported problems

Abiomed, Inc. · ABMD Introducer Kit, 14Fr x Short, Pkgd · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

19 other recalls cover devices cleared under the same FDA submission (K192769); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

Jun 11, 2026Open, Classified
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Z-2685-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192769. One submission often covers many models, so check the product and lot details in each record.

Z-2684-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
Z-2692-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Z-2690-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Z-2688-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Z-2687-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Z-2681-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
Z-2691-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
Z-2683-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump an
Z-2693-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Z-2682-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Z-2689-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
Z-2686-2026 · Jun 11, 2026 · Open, Classified
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and acces
Z-0647-2024 · Nov 7, 2023 · Open, Classified
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Z-0646-2024 · Nov 7, 2023 · Open, Classified
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (
Z-0649-2024 · Nov 7, 2023 · Open, Classified
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 C

…and 4 more.

Device details

UDI-DI	`00813502011708`
Brand	Impella
Model	0052-0038
Company	Abiomed, Inc.
Product code	DYB · Introducer, Catheter
Class	Class 2
FDA submission	K192769
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 20, 2024

Device type (GMDN): Vascular catheter introduction set, nonimplantable

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Other Introducer, Catheter devices

VIZIGO D138502
Biosense Webster Inc · INTRODUCER, CATHETER
2 recalls4 deaths2,839 reports
VIZIGO D138501
Biosense Webster Inc · INTRODUCER, CATHETER
2 recalls2 deaths2,005 reports
Swartz™ 407451
St. Jude Medical, Inc. · INTRODUCER, CATHETER
5 deaths728 reports
Edwards eSheath+ Introducer set 914ESP
Edwards Lifesciences LLC · Introducer, Catheter
22 deaths532 reports
Fast-Cath™ 406849
St. Jude Medical, Inc. · INTRODUCER, CATHETER
420 reports
VIZIGO D138503
Biosense Webster Inc · INTRODUCER, CATHETER
362 reports
Agilis™ G408318
St. Jude Medical, Inc. · INTRODUCER, CATHETER
333 reports
Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-M
St. Jude Medical, Inc. · Introducer, catheter
1 death301 reports

All Introducer, Catheter devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page