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Recall Observatory FDA recall evidence

Device product

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

Z-1552-2021

March 25, 2021

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 87656
Status
Terminated
Classification
Class II
Quantity
287 units
Official record key
device-enforcement:Z-1552-2021

Official wording

Reason: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

Code information: Code: REEV2356, REEX1383, REEX3996

Distribution pattern: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.