Z-0653-2024Class II

Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction...

Name: Z-0653-2024 Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction...
Creator: Abiomed, Inc.
Published: 2023-11-07
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2023-11-07 / Open, Classified / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part... on 2023-11-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0653-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-07
Posted: 2024-01-05
Recalling firm: Abiomed, Inc.
Product: Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
Product code: DYB Introducer, Catheter
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Abiomed issued URGENT MEDICAL DEVICE RECALL (REMOVAL) Letter Products Impacted: Introducer Kit for Impella (sold within Impella Pump sets and Individually Packaged) Axillary Introducer Kits on 11/7/23. Letter states reason for recall, health risk and action to take: IF AN IMPELLA PUMP IS CLINICALLY NEEDED, ACTIONS TO BE TAKEN BY THE USER: 1. Prior to usage, carefully examine the outer pouch of the Introducer Kit for holes following the provided instructions in Attachment 2. 2. For non-trayed introducers (Part Numbers 0052-3006): IF THERE IS ANY SUSPICION OF THIS TYPE OF PACKAGING DAMAGE, REFRAIN FROM USING THE PRODUCT. 3. For trayed introducers with an inner tray package (Part Numbers 0052-3014, 0052-3015, 0052-3021, 0052-3052, 0052-3046, 0052-3025, 0052-3056, 2000342, 0052-3053): Consider that while the outside surface of the tray is non-sterile, the introducers inside the tray are considered sterile. After removing the inner tray from the outer pouch, avoid introducing it to the sterile field. Instead, employ sterile technique to open the inner tray, preserving its interior sterility. a. Transfer the contents from the inner tray to the sterile field following your institution s sterile field management protocol, ensuring no contact with the outer surface to prevent contamination. b. The inner tray must remain separate from the sterile field and should be discarded once all components of the introducer kit have been extracted. 4. If used, document the use on the Business Request Form at the end of this letter. Please contact Abiomed s Clinical Support Center, 1-800-422-8666, if you need any support troubleshooting or if you have any further questions.
Quantity in commerce: 1 unit within kit
Distribution: 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
Product codes and lots: UDI-DI: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0653-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0646-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0647-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0648-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0649-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0650-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0651-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0652-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0653-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0654-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0655-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)