FDAApril 16, 2018device
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
What to do
FDA enforcement status: Terminated
Brands named
bard peripheral vascularbardbard peripheral
UPCs
00801741067921
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASilastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 336242026-04-23
- FDAArtegraft Vascular Graft; REF#: AG740;2026-02-10
- FDABroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 600602025-12-12
- FDABD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 7884262025-11-06
- FDABD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 7886302025-11-06
- FDABD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 788262025-11-06
- FDASafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,2025-11-06
- FDABard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 7876142025-11-06
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