Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
FDA adverse event reports and recall history for biliary catheter for stone removal that may also allow for irrigation and contrast injection (product code GCA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 438
- Deaths
- 1
- Injuries
- 79
- Malfunctions
- 356
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-07-24TerminatedOther
Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
- 2003-10-24TerminatedOther
Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.
The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
Monitor biliary catheter for stone removal that may also allow for irrigation and contrast injection automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.