The Recall Desk
HighFDA (Devices)·Z-2388-2019·Announced 2019-09-04

Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

Bard Peripheral Vascular Inc is recalling 570 units of 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 (tip breakage) during a medical procedure, which poses a risk of harm, but the source text does not report specific injuries or hospitalizations, 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 570 units of GlidePath Long-Term Hemodialysis Catheters (REF/Product code: 5396240, 14.5F, Alphacurve, 19cm length). The recall involves specific lots with expiration dates in July and August 2020.

The action was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. The affected units were distributed across the United States and in Australia and Canada.

Healthcare providers and patients should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the product is in use, it should be removed from service and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
570

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)

  • (Lot #
  • Exp.) RECZ1119 8/31/2020
  • RECX2706 7/31/2020
  • RECX1189 8/31/2020
  • RECX0986 8/31/2020

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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