Z-1467-2021Class II

AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 -

Name: Z-1467-2021 AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 -
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2021-02-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-02-22 / Terminated / root cause: sterility

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of... on 2021-02-22. FDA classified it as Class II and gives the reason as "AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1467-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-22
Posted: 2021-04-21
Terminated: 2022-07-19
Recalling firm: Boston Scientific Corporation
Product: AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Product code: DYB Introducer, Catheter
Reason for recall: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On 2/22/2021, AngioDynamics issued an Urgent Medical Device Recall notice via letter informing customers the package integrity of specific Valved Introducers may be susceptible to failure, resulting in the potential for compromised sterility of the device.
Quantity in commerce: 337 units, (14 boxes of 5, 267 units each kit)
Distribution: US Nationwide distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.
Product codes and lots: UPN: VI10, Lot #: DP-11759

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1467-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1466-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21
Z-1467-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-21

Product code DYB

K122084Class IIIntroducer Set, Model Adelante-S SeriesOscor, Inc. / cleared 2012-08-29

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)