Data Foundry

Medical device recalls 2019

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet — Class II medical device recall Z-2394-2019

Terminated recall by Bard Peripheral Vascular Inc, reported 2019-09-04, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or

Recall numberZ-2394-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBard Peripheral Vascular Inc, Tempe, AZ, United States
Recall initiated2019-05-31
Classified2019-08-26
Reported by FDA2019-09-04
Terminated2022-05-17
DistributedAK, 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
Countries outside the USAU, CA
Quantity39 units
UPC / GTIN / UDI-DI00801741012334
Lot numbersREDN1398
Expiration dates2020-03-31

Product

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334

Reason for recall

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2394-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.