Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues
Bard Peripheral Vascular Inc. is recalling 2,194 PowerPort duo M.R.I. Implantable Ports due to potential catheter flushing, infusion, and aspiration difficulties, as well as septum dislodgement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes functional defects (flushing/infusion difficulties and septum dislodgement) in a medical device without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling 2,194 units of the PowerPort duo M.R.I. Implantable Port, which includes an attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter. The affected product is identified by reference number 1829500 and UDI (01) 00801741027185. The port system is designed for the infusion of medications, intravenous fluids, parenteral nutrition solutions, and blood products, as well as for the withdrawal of blood samples.
The recall was initiated because the catheters may experience difficulty in flushing, infusion, and/or aspiration, and there is a risk of septum dislodgement. The agency has classified this as a Class II recall.
The affected units were distributed nationwide in the United States, specifically 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, and WV. The specific lot codes for the recalled units are REEU3063, REEV0989, REEV2633, REEX1380, and REEZ1991. Healthcare providers and patients should check their device reference numbers and lot codes to determine if they are affected.
The recalled product
- Product
- PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood produc
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 2,194
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Code: REEU3063
- REEV0989
- REEV2633
- REEX1380
- REEZ1991
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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