8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF recallZ-0056-2012 · 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-0056-2012
- 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
- K062414
- 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 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. Polyurethane Catheters and 8Fr. Introducer Kit.
Code information (models, lots, serial numbers)
Catalog number: CT80STPD and CT80STPD-NF
Other devices under the same FDA submission
27 devices cleared under K062414 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Smart Port CT CT80STPDAngiodynamics, Inc. · Set, administration, intravascular2 deaths73 reports
- Smart Port CT CT80STPD-VIAngiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death54 reports
- Smart Port CT H787CT80STPD0Angiodynamics, Inc. · Set, administration, intravascular2 deaths49 reports
- Smart Port CT H787CT80STPDVI1Angiodynamics, Inc. · Set, administration, intravascular1 death43 reports
- Smart Port CT CT75STSDAngiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR23 reports
- Smart Port CT H787CT96STSD0Angiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR20 reports
- Smart Port CT CT96STSDAngiodynamics, Inc. · Set, administration, intravascular18 reports
- Smart Port CT H787CT75STSD0Angiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 death14 reports
- Smart Port CT CT75STSAAngiodynamics, Inc. · Set, administration, intravascular14 reports
- Smart Port CT H787CT96STSDVI1Angiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths8 reports
- Smart Port CT CT80STPA-VIAngiodynamics, Inc. · Set, administration, intravascular8 reports
- Smart Port CT CT80STPD-NFAngiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 59526).
- Z-0055-2012 · Terminated8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedu…
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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