The Recall Desk
SevereFDA (Devices)·Z-2386-2019·Announced 2019-09-04

Bard GlidePath Hemodialysis Catheter Recalled for Tip Damage

Bard Peripheral Vascular Inc. is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a medical device defect that poses a risk of injury during a procedure is rated as Severe (4), as it is a significant injury risk but not classified as Class I.

Plain-English summary

Bard Peripheral Vascular Inc. is recalling 713 units of the GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet. The specific product code is 5393420, 14.5F, Straight, 42cm length, with UDI 00801741012228. The affected lots are RECZ2997, RECX0854, RECW0386, and RECX1190, with expiration dates ranging from January 31, 2020, to August 31, 2020.

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 to patients during the medical procedure.

The product was distributed to facilities in 49 US states, the District of Columbia, Puerto Rico, the US Virgin Islands, Australia, and Canada. Healthcare providers and patients should contact Bard Peripheral Vascular Inc. for instructions on how to return or replace the affected devices.

The recalled product

Product
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
713

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.) RECZ2997 8/31/2020
  • RECX0854 3/31/2020
  • RECW0386 7/31/2020
  • RECX1190 1/31/2020

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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Same hazard · device defect

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