The Recall Desk
HighFDA (Devices)·Z-2376-2019·Announced 2019-09-04

Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

Bard Peripheral Vascular Inc is recalling Equistream XK Alphacurve Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

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 involves a medical device defect (tip breakage) that poses a risk of harm during a procedure, but the source text does not report specific injuries or fatalities, 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 Equistream XK Alphacurve Long-Term Hemodialysis Catheters, product code 5915240, 16F, 24cm length, UDI 00801741013904. The recall involves Lot # REDN1368 with an expiration date of 9/30/2020. The product was distributed in the United States and internationally, including Australia and Canada.

The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. This defect poses a risk of injury to patients during the medical procedure.

Healthcare providers and patients should stop using the affected catheters and contact Bard Peripheral Vascular Inc for further instructions or replacement.

The recalled product

Product
EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904

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 (1)

  • Lot # REDN1368 Exp. 9/30/2020

Distribution

Part of a larger recall action

This product is one of 28 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 28 products in this recall →