The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2383-2019·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 be damaged during placement.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 the hazard involves a structural defect in a medical device used in a high-risk procedure (hemodialysis catheter placement), which poses a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 7,070 units of GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet (REF/Product code: 5393190, 14.5F, Straight, 19cm length). The recall 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 all 50 U.S. states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as in Australia and Canada. Specific lot numbers and expiration dates are listed in the structured product information.

Healthcare providers should stop using the affected catheters and contact Bard Peripheral Vascular Inc for further instructions. Patients who have had these catheters placed should consult their healthcare provider if they have concerns.

The recalled product

Product
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
7,070

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 (13)

  • (Lot #
  • Exp.) REDN2496 9/30/2020
  • REDN0142 7/31/2020
  • RECZ1104 7/31/2020
  • RECZ0651 4/30/2020
  • RECW2475 3/31/2020
  • RECX0509 3/31/2020
  • RECX1199 4/30/2020
  • RECW1846 3/31/2020
  • RECW0961 9/30/2020
  • RECW0095 8/31/2020
  • RECX1120 7/31/2020
  • RECV1690 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 →

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