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FlowMedical PTA-CATH 5,0 x 100 Angioplasty Catheter of the manufacturer itm FlowMedical GmbH

Case no. 5873/11

BfArM cancels the recommendation below. Meanwhile the affected catheter was investigated by the legal successor and no manufacturing related deficiency could be identified.

We were informed, after a brachytherapy when the Rhenium-188 filled balloon was evacuated blood was visible in the aspirate.
First investigations indicated, that the balloon was probably damaged from contact with a stent.
Because the manufacturer discontinued all business activities completely, the investigation of the case could not be completed and finally assessed by the manufacturer. A systematic device deficiency could not definitely be excluded.
Therefore, we recommend that the affected devices should not be used anymore.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 228 207-5382 (Non-active medical devices)
Facsimile: +49 228 207-5300