The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0212-2018·Announced 2017-12-13

Biosense Webster Recalls PENTARAY NAV Mapping Catheters Due to Labeling Update

Biosense Webster is recalling 73,796 PENTARAY NAV High-Density Mapping Catheters to update contraindication language in the Instructions For Use regarding prosthetic valves.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling update to clarify contraindications. The source text does not report any illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.

Plain-English summary

Biosense Webster, Inc. is recalling 73,796 units of the PENTARAY NAV High-Density Mapping Catheter. The recall is being conducted to update the contraindication language in the Instructions For Use (IFU). The updated documentation indicates that Pentaray Catheters should not be used in patients with prosthetic valves.

The affected product codes are D-1282-07-S, D-1282-08-S, D-1282-09-S, D-1282-10-S, D-1282-11-S, and D-1282-12-S. The devices were distributed nationwide and internationally to numerous countries including 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 Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and the United Kingdom.

This recall is classified as Class II by the FDA. The source text does not report any specific illnesses or injuries associated with the use of these devices. Healthcare providers and consumers should refer to the updated Instructions For Use to ensure the device is not used in patients with prosthetic valves.

The recalled product

Product
PENTARAY NAV High-Density Mapping Catheter.
Manufacturer
Biosense Webster, Inc.
Category
Medical Device — Cardiac Catheter
Hazard
Affected units
73,796

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Biosense Webster, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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