FDA | 合法醫療器材資訊網

2020年5月1日—VascularSolutions,Inc.hasannounceditisrecallingtheLangstonDualLumenCatheterinresponsetoreportsthattheinnercathetermay ...

There have been eight complaints about the potential for the inner catheter to separate during use.

Vascular Solutions, Inc. has announced it is recalling the Langston Dual Lumen Catheter in response to reports that the inner catheter may separate during use. The US Food and Drug Administration has deemed it a Class I device recall, the most serious type.

The recall of model number 6F 5540 affects 4,304 devices distributed in the US between July 12, 2019 and March 10, 2020. According to Vascular Solutions, Inc, separation of the inner catheter “could cause serious health conditions including additional surgical procedures to remove the separated section, damage to the blood vessel or death. If the inner catheter separates outside of the patient’s body, the dye could spray the doctor and lead to an infection that may require the doctor to receive treatment.”

Eight complaints have been rece...

The Langston is Gone For Now (No More Dual Lumen Pigtail ... | 合法醫療器材資訊網

2021年4月5日 — Watch/listen to the April 29, 2021 Clinical Editor's Corner Live video ... While the small aortic lumen of the Langston pigtail catheter was, ... However, the 6 Fr dual lumen pigtail (Langston) catheter was recalled last year ... Read More

Vascular Solutions | 合法醫療器材資訊網

2020年4月30日 — Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use ... The FDA has identified this as a Class I ... Read More

Dimitris Barlagiannis on Twitter | 合法醫療器材資訊網

2020年9月4日 — Video follows! ... Also caution while entering the LV so that the cath will not be bent at the point where the back end attaches to the shaft of cath. Read More

FDA Medical Devices on Twitter: "Today, the | 合法醫療器材資訊網

2020年4月30日 — Vascular Solutions, Inc. recalled the Langston Dual Lumen catheter because the inner catheter may separate during or after a high-pressure ... Read More

Langston Dual Lumen Catheter Recalled for Separation Risk ... | 合法醫療器材資訊網

2020年5月5日 — Langston Dual Lumen Catheter Recalled for Separation Risk ... Vascular Solutions Inc. has recalled the Langston Dual Lumen Catheter because ... Read More

Langston® Dual Lumen Catheters | 合法醫療器材資訊網

Langston® Dual Lumen Catheters provide accurate and stable pressure measurements through two lumens in a coaxial design. The Langston® Pigtail Catheter ... Read More

Simultaneous Measurement of Differential Pressures With a ... | 合法醫療器材資訊網

Physicians need to be precise in their diagnostic measurements. The Langston Dual Lumen Catheter, which is designed to simultaneously and accurately ... Read More

BRIEF | 合法醫療器材資訊網

FDA SAYS VASCULAR SOLUTIONS RECALLS LANGSTON DUAL LUMEN CATHETER DUE TO RISK OF SEPARATION DURING USE. Read More

FDA | 合法醫療器材資訊網

2020年5月1日 — Vascular Solutions, Inc. has announced it is recalling the Langston Dual Lumen Catheter in response to reports that the inner catheter may ... Read More

Vascular Solutions recall of Langston dual lumen catheter is ... | 合法醫療器材資訊網

2020年4月30日 — The company is recalling the catheter because of the potential that the inner catheter may separate during use, which can cause serious health ... Read More

相關資訊整理