Z-0055-2012

8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized...

Name: Z-0055-2012 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized...
Creator: Angiodynamics, INC
Published: 2011-08-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-08-01 / Terminated / root cause: design

FDA source

Angiodynamics, INC began a recall of 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port... on 2011-08-01. The reason FDA records is "The product may contain an incorrect size catheter and introducer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0055-2012
Status: Terminated
Initiated: 2011-08-01
Posted: 2011-10-13
Terminated: 2012-03-07
Recalling firm: Boston Scientific Corporation
Product: 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.
Product code: DYB Introducer, Catheter
Reason for recall: The product may contain an incorrect size catheter and introducer.
Root cause tag: design
FDA root cause: Device Design
Action: AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011. The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF). For question on this recall contact AngioDynamics, Inc at (800) 772-6446.
Quantity in commerce: 1095 total units
Distribution: (USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI.
Product codes and lots: Catalog number: V18, Lot numbers D1-01664 and D101799

Product code DYB

K073100Class IIIntroducer Sets, Models Adelante and Adelante-SOscor, Inc. / cleared 2007-11-30

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)