The Recall Desk
HighFDA (Devices)·Z-2385-2019·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 and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Bard Peripheral Vascular Inc is recalling specific lots of GlidePath Long-Term Hemodialysis Catheters with Preloaded Stylet. The recall involves 2,298 units of the 14.5F, Straight, 27cm length catheters (REF/Product code: 5393270). The affected lots are REDN4346, RECZ2996, RECX1128, RECX1122, and RECX1195.

The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. The agency has classified this as a Class II recall. The products were distributed across the United States, including all 50 states, DC, Puerto Rico, and the U.S. Virgin Islands, as well as in Australia and Canada.

Healthcare facilities and consumers should stop using the affected catheters and contact Bard Peripheral Vascular Inc for instructions on return or replacement. The recall number is Z-2385-2019.

The recalled product

Product
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
2,298

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 (6)

  • (Lot #
  • Exp.) REDN4346 9/30/2020
  • RECZ2996 7/31/2020
  • RECX1128 3/31/2020
  • RECX1122 8/31/2020
  • RECX1195 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 →

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