The Recall Desk
HighFDA (Devices)·Z-2390-2019·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 involves a medical device defect (tip breakage) that poses a risk of harm during a procedure, but the source text does not report any 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 1,679 units of the GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet (REF/Product code: 5397190, 14.5F, straight, 19cm length). The recall is initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure.

The affected units are distributed across numerous US states and territories, as well as Australia and Canada. Specific lot numbers and expiration dates are listed in the agency's structured data, including REDN2429, REDN0140, RECZ1125, RECX0511, RECW2477, RECW1716, and RECW0390.

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
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
1,679

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 (8)

  • (Lot #
  • Exp.) REDN2429 9/30/2020
  • REDN0140 3/31/2020
  • RECZ1125 7/31/2020
  • RECX0511 7/31/2020
  • RECW2477 3/31/2020
  • RECW1716 3/31/2020
  • RECW0390 3/31/2020

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 · device failure

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