The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2391-2019·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. 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 fatalities, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 899 units of GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet (REF/Product code: 5397230, 14.5F, straight, 23cm length). The recall is being 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 in the United States (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY) and in Australia and Canada. Specific lot numbers and expiration dates include REDN4412 (12/31/2020), RECZ0753 (3/31/2020), RECW0970 (3/31/2020), and RECW0387 (6/30/2020).

Healthcare providers and patients should check their inventory and records for these specific product codes and lot numbers. If the product is in use or stock, it should be removed from service and returned to the manufacturer or disposed of according to local regulations. No specific instructions for patient management are provided in the source text beyond the identification of the defect.

The recalled product

Product
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
899

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.) REDN4412 12/31/2020
  • RECZ0753 3/31/2020
  • RECW0970 3/31/2020
  • RECW0387 6/30/2020

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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