The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2371-2020·Announced 2020-06-24

Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the heart's valves during use.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (catheter entrapment in the heart) where no injuries or illnesses have been reported in the source text, meeting the criteria for a High severity score.

Plain-English summary

Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters, which are used for electrophysiological mapping of cardiac structures. The recall covers specific product codes D-1282-07, D-1282-08, D-1282-10, and D-1282-11. The agency classifies this as a Class II recall.

The recall is being issued because the mapping catheter can become entrapped in the cardiac valvular apparatus while a user is attempting to create an electroanatomic map. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

The affected devices were distributed worldwide, including across the United States and in various countries in Europe, Asia-Pacific, Latin America, and Canada. Healthcare providers and facilities that have these specific product codes should stop using the devices and contact the manufacturer for further instructions.

The recalled product

Product
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e.…
Manufacturer
BIOSENSE WEBSTER
Category
Medical Device — Cardiac Catheter
Hazard

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)

  • This field action includes all lots of the following product codes: D-1282-07
  • D-1282-08
  • D128202
  • D128203
  • D128204
  • D128205
  • 7FR
  • F
  • 4-4-4 10846835009576 D-1282-02-S PENTARAY¿ NAV
  • 2-6-2 10846835009583 D-1282-03-S PENTARAY¿ NAV
  • 1-8-1 10846835009590 D-1282-04-S PENTARAY¿ NAV
  • D
  • 4-4-4 10846835009606 D-1282-05-S PENTARAY¿ NAV
  • 2-6-2 10846835009613 D-1282-06-S PENTARAY¿ NAV

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 2 recalled by BIOSENSE WEBSTER 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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