Biosense Webster, Inc.: PENTARAY NAV High-Density Mapping Catheter.

Is my product affected?

PENTARAY NAV High-Density Mapping Catheter.

• UPC 10846835009576
• UPC 10846835009583
• UPC 10846835009590
• UPC 10846835009606
• UPC 10846835009613
• UPC 10846835009620

Check against the official notice below — it lists the full affected range.

What happened

Biosense Webster, Inc. is recalling 73,796 units of PENTARAY NAV High-Density Mapping Catheters distributed nationwide and internationally because updated instructions for use now indicate that these catheters should not be used in patients with prosthetic valves. The recall affects six product codes with varying specifications, all in 7FR size.

The recall has been distributed to numerous countries across multiple continents, including the United States, Canada, Australia, Japan, and throughout Europe. The source document does not specify what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

Details from the source

Reason for recall: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. Distribution: Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zeal Quantity: 73,796 units total Lot/code info: Product code (Product Description) (GTIN): D-1282-01-S (NAV, 7FR, F, 4-4-4) (10846835009576), D-1282-02-S (NAV, 7FR, F, 2-6-2) (10846835009583), D-1282-03-S (NAV, 7FR, F, 1-8-1) (10846835009590), D-1282-04-S (NAV, 7FR, D, 4-4-4) (10846835009606), D-1282-05-S (NAV, 7FR, D, 2-6-2) (10846835009613), D-1282-06-S (NAV, 7FR, D, 1-8-1) (10846835009620).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls