The Recall Desk
HighFDA (Devices)·Z-2387-2019·Announced 2019-09-04

Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

Bard Peripheral Vascular Inc is recalling GlidePath 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 is classified as FDA Class II. The hazard involves a structural defect in a medical device that can cause injury during a procedure, fitting the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 240 units of the GlidePath Long-Term Hemodialysis Catheter (REF/Product code: 5396190, 14.5F, Alphacurve, 19cm length). The specific lot affected is RECX2538, with an expiration date of 7/31/2020. The product is identified by UDI 00801741012242.

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 or procedural failure during the medical intervention.

The affected units were distributed to facilities in the United States, including all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as in Australia and Canada. Healthcare providers and patients should stop using the affected lots and contact Bard Peripheral Vascular Inc for further instructions or replacement.

The recalled product

Product
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
240

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 # RECX2538 Exp. 7/31/2020

Distribution

Distributed in 53 states:

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 →

Related recalls

Same manufacturer · Bard Peripheral Vascular Inc

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Same hazard · structural defect

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