Exact FDA event identifier

Event 77529

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 17, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Biosense Webster, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

PENTARAY NAV High-Density Mapping Catheter.

Z-0211-2018

Recall number: Z-0211-2018
Initiated: May 17, 2017
Classification: Class II
Status: Terminated
Recalling firm: Biosense Webster, Inc.
Quantity: 73,796 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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 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, United Kingdom.

device · product 2 of 2

PENTARAY NAV High-Density Mapping Catheter.

Z-0212-2018

Recall number: Z-0212-2018
Initiated: May 17, 2017
Classification: Class II
Status: Terminated
Recalling firm: Biosense Webster, Inc.
Quantity: 73,796 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).