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

Is my product affected?

PENTARAY NAV High-Density Mapping Catheter.

• UPC 10846835012217
• UPC 10846835012224
• UPC 10846835012231
• UPC 10846835012248
• UPC 10846835012255
• UPC 1846835012262

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

What happened

Biosense Webster is recalling 73,796 units of PENTARAY NAV High-Density Mapping Catheters due to updated contraindication language in the product's instructions for use. The catheters should not be used in patients with prosthetic valves. The recalled catheters were distributed nationwide and internationally across numerous countries, including Canada, Mexico, Japan, Australia, and many European nations.

The recall affects six product codes of NAV ECO 7FR catheters with various configurations. The source document does not specify a remedy for affected consumers or what actions they should take in response to this recall.

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-1282-07-S (NAV ECO 7FR, F, 4-4-4) (10846835012217), D-1282-08-S (NAV ECO 7FR, F, 2-6-2) (10846835012224), D-1282-09-S (NAV ECO 7FR, F, 1-8-1) (10846835012231), D-1282-10-S (NAV ECO 7FR, D, 4-4-4) (10846835012248), D-1282-11-S (NAV ECO 7FR, D, 2-6-2) (10846835012255), D-1282-12-S (NAV ECO 7FR, D, 1-8-1) (1846835012262).

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