8F Safe Sheath Introducer, Catalog number: V18 recallZ-0055-2012 · Angiodynamics, INC · initiated Aug 1, 2011
Terminated All recalls posted in October 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics, INC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product may contain an incorrect size catheter and introducer.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0055-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 1, 2011
- Posted by the FDA
- Oct 13, 2011
- Recalling firm
- Angiodynamics, INC
- Quantity
- 1095 total units
- Product code
- DYB
- FDA submissions
- K073100
- 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 description
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.
Code information (models, lots, serial numbers)
Catalog number: V18, Lot numbers D1-01664 and D101799
Other devices under the same FDA submission
10 devices cleared under K073100 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SafeSheath® Ultra Lite VI10Oscor Inc. · INTRODUCER, CATHETER1 recall2 reports
- SafeSheath® Ultra Lite VI7Oscor Inc. · INTRODUCER, CATHETER13 reports
- SafeSheath® Ultra Lite VI85Oscor Inc. · INTRODUCER, CATHETER9 reports
- Adelante Peel-Away Introducer Set AP06016B5Oscor Inc. · INTRODUCER, CATHETER4 reports
- Adelante Peel-Away Introducer Set AP07016B5Oscor Inc. · INTRODUCER, CATHETER4 reports
- Adelante SafeSheath Ultra Lite ASUP131318POscor Inc. · INTRODUCER, CATHETER1 report
- Adelante SafeSheath Ultra Lite ASUP151318POscor Inc. · INTRODUCER, CATHETER1 report
- Adelante Peel-Away Introducer Set AP08016B5Oscor Inc. · INTRODUCER, CATHETER1 report
- Adelante Peel-Away Introducer Set AP09016B5Oscor Inc. · INTRODUCER, CATHETER1 report
- Adelante SafeSheath Ultra Lite ASUP071318POscor Inc. · INTRODUCER, CATHETER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 59526).
- Z-0056-2012 · Terminated8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyur…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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