Food, drugs, devices › Biosense Webster, Inc.
Device recall: PENTARAY NAV High-Density Mapping Catheter.
FDA enforcement event 77529 is a device recall by Biosense Webster, Inc. of Irwindale, CA, initiated 17 May 2017 and classified Class II, with 2 product records.
FDA defines Class II as 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 15 Dec 2020. Initiation: voluntary: firm initiated. Biosense Webster, Inc. has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Biosense Webster, Inc., Irwindale, CA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0211-2018 | PENTARAY NAV High-Density Mapping Catheter. | 73,796 units total | Class II | Terminated | 13 Dec 2017 |
| Z-0212-2018 | PENTARAY NAV High-Density Mapping Catheter. | 73,796 units total | Class II | Terminated | 13 Dec 2017 |
Context
Other enforcement events for Biosense Webster, Inc.
All 21 events for Biosense Webster, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Dec 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.