Z-2128-2023Class II

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Name: Z-2128-2023 Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Creator: Abiomed, Inc.
Published: 2023-05-26
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2023-05-26 / Open, Classified / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 on 2023-05-26. FDA classified it as Class II and gives the reason as "There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally...". 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-2128-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-26
Posted: 2023-07-11
Recalling firm: Abiomed, Inc.
Product: Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Product code: DYB Introducer, Catheter
Reason for recall: There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An URGENT: VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) notification letter was delivered to customers on 5/23/23. Customers were also contacted via telephone on 5/26/23. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal). DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your Abiomed local clinical field staff to coordinate the return of the subject products. 3. Review, complete all fields, sign, and return the attached Business Response Form (BRF) on the last page of this letter to the Recall Coordinator identified in this document. 4. Forward this notice to any personnel in your facility who needs to be informed. 5. If any of the product subject to this recall (removal) has been forwarded to another facility, contact that facility immediately and provide a copy of this notice to the relevant personnel. 6. Post a copy of this field safety notice in a visible area for awareness. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting Program using the link below: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reportingprogram/reporting-serious-problems-fda If you have questions or concerns regarding this notice, please contact (Shashi Thoutam) directly at +1(734) 262-6255 and/or your local clinical field staff.
Quantity in commerce: 37 units
Distribution: US Nationwide distribution in the states of MN, NJ, TN.
Product codes and lots: UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2128-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2128-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-11

Product code DYB

K222113Class IIAbiomed 14Fr Low Profile Introducer SetAbiomed, Inc. / cleared 2022-10-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)