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Personal Catheter™ Intermittent Catheter

C. R. Bard, Inc. · Model 63310 · UDI-DI 00801741069154

KOD Prescription
10
510(k) clearances
17,035
Adverse events (29 deaths)
107
Recalls
111
Facilities

Description

Personal Catheter™ Silicone Intermittent Urinary Catheter, Male

Recalls

DateFirmReason
2025-06-03C.R. Bard IncCather packaging may contain the incorrect French size.
2025-06-03C.R. Bard IncCather packaging may contain the incorrect French size.
2023-12-04Cardinal Health 200, LLCConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2022-09-20TELEFLEX LLCProduct may not be sterile
2022-01-27C.R. Bard IncThere is a potential to leak from the catheter where it connects to the drain bag
2022-01-27C.R. Bard IncThere is a potential to leak from the catheter where it connects to the drain bag
2021-01-11C.R. Bard, Inc.The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
2020-04-30Covidien LlcTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead
2020-04-30Covidien LlcTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead
2020-04-30Covidien LlcTemperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.