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ARROW

TELEFLEX INCORPORATED · Model IPN000081 · UDI-DI 00801902002259

DYG Prescription

510(k) clearances

4,863

Adverse events (139 deaths)

Recalls

Facilities

Description

Berman Angiographic Balloon Catheter

Recalls

Date	Firm	Reason
2026-04-08	Becton, Dickinson and Company	Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl
2026-04-08	Becton, Dickinson and Company	Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or bl
2025-04-11	LeMaitre Vascular, Inc.	During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
2023-02-14	Edwards Lifesciences, LLC	There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error
2023-02-14	Edwards Lifesciences, LLC	There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error
2019-11-15	Arrow International Inc	Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowl
2019-11-15	Arrow International Inc	Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowl
2018-12-21	Edwards Lifesciences, LLC	These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values a
2018-12-21	Edwards Lifesciences, LLC	These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values a
2018-12-21	Edwards Lifesciences, LLC	These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values a

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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.