Berman Angiographic Balloon Catheter (2019-11-20)

Starting date:

November 20, 2019

Posting date:

December 13, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71865

Last updated: 2019-12-13

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  Reason
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  Affected products

Affected Products

Berman Angiographic Balloon Catheter

Reason

Teleflex has found extension line leaks on the balloon extension line during quality inspection for a lot of catheters. The leak will cause the balloon to deflate slowly and appears to be caused by two parallel scratches or cuts coming from outside the extension (one on the printed side, one on the non-printed side) and can leak from one or both scratches or cuts.

Affected products