Agency classClass IIOur severity:High FDA (Devices)·Z-1552-2021·Announced 2021-05-19

Bard PowerPort duo M.R.I. Implantable Port Recall for Catheter Issues

Bard Peripheral Vascular Inc. is recalling 287 PowerPort duo M.R.I. Implantable Ports due to catheter flushing difficulties and septum dislodgement.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a high-risk medical device (implantable port) with functional defects (flushing/infusion difficulties) that pose a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Bard Peripheral Vascular Inc. is recalling 287 units of the PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter (REF 5829502). The recall is due to reports that the catheters may experience difficulty in flushing, infusion, and/or aspiration, as well as septum dislodgements.

The affected products 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 associated with this recall are REEV2356, REEX1383, and REEX3996.

Healthcare providers and patients should contact Bard Peripheral Vascular Inc. for further instructions on how to manage the affected devices. The port system is used for the infusion of medications, I.V. fluids, parenteral nutrition solutions, and blood products, as well as for the withdrawal of blood samples.

The recalled product

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…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Implantable Port
Hazard: device-malfunction
infusion-difficulty
septum-dislodgement
Affected units: 287

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 (3)

Code: REEV2356
REEX1383
REEX3996

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

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.

See all 3 products in this recall →

Same manufacturer · Bard Peripheral Vascular Inc

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