The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0211-2018·Announced 2017-12-13

Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because the instructions for use were updated to indicate they should not be used in patients with 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: This is an FDA Class II recall involving a documentation update to clarify contraindications. The hazard is theoretical as no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity score.

Plain-English summary

Biosense Webster, Inc. is recalling 73,796 units of PENTARAY NAV High-Density Mapping Catheters. The recall was initiated 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 products 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 United Kingdom.

Healthcare providers and patients should review the updated Instructions For Use to ensure the device is not used in patients with prosthetic valves. The specific product codes affected are D-1282-01-S, D-1282-02-S, D-1282-03-S, D-1282-04-S, D-1282-05-S, and D-1282-06-S.

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 (15)

  • Product code (Product Description) (GTIN): D-1282-01-S (NAV
  • 7FR
  • F
  • 4-4-4) (10846835009576)
  • D-1282-02-S (NAV
  • 2-6-2) (10846835009583)
  • D-1282-03-S (NAV
  • 1-8-1) (10846835009590)
  • D-1282-04-S (NAV
  • D
  • 4-4-4) (10846835009606)
  • D-1282-05-S (NAV
  • 2-6-2) (10846835009613)
  • D-1282-06-S (NAV
  • 1-8-1) (10846835009620).

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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