PENTARAY NAV D128203Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835009590), received between Jun 21, 2024 and Jun 21, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

2 FDA recall records name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K120425); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 22, 2020Terminated

   Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

   Z-2371-2020 · Root cause: Error in labeling · FDA record ↗

2. May 17, 2017Terminated

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

   Z-0211-2018 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TIJSKENS M, ABUGATTAS JP, THOEN H, STRAZDAS A, SCHWAGTEN B, WOLF M, DE GREEF Y. ADDING ELECTROANATOMICAL MAPPING TO CRYOBALLOON PULMONARY VEIN ISOLATION IMPROVES 1-YEAR CLINICAL OUTCOME AND DURABILITY OF PULMONARY VEIN ISOLATION: A PROPENSITY SCORE-MATCHED ANALYSIS. J CARDIOVASC DEV DIS. 2024 FEB 6;11(2):57. DOI: 10.3390/JCDD11020057. PMID: 38392271; PMCID: PMC10889252. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: ADDING ELECTROANATOMICAL LEFT ATRIAL (LA) VOLTAGE MAPPING TO CRYOBALLOON ABLATION (CBA) IMPROVES VALIDATION OF ACUTE PULMONARY VEIN ISOLATION (PVI). AIMS: TO DETERMINE WHETHER THE ADDITION OF MAPPING CAN IMPROVE OUTCOME AND PVI DURABILITY. METHODS: ONE-YEAR OUTCOME AND PV RECONNECTION (PVR) RATE AT FIRST REPEAT ABLATION WERE STUDIED IN 400 AF PATIENTS IN A PROPENSITY-MATCHED ANALYSIS (AGE, AF TYPE, CHA2DS2-VASC SCORE) BETWEEN ACHIEVE CATHETER-GUIDED CBA WITH ADDITIONAL ENSITE LA VOLTAGE MAPS PERFORMED PRE- AND POST-CBA (MAPPING GROUP; N = 200) AND CT- AND ACHIEVE CATHETER-GUIDED CBA (CONTROL GROUP; N = 200). CLINICAL SUCCESS WAS DEFINED AS FREEDOM OF DOCUMENTED AF OR ATRIAL TACHYCARD

  Patient problems: Air Embolism; Pericarditis; Stroke/CVA

  MAUDE report 19588566 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120425. One submission often covers many models, so check the product and lot details in each record.

• Z-0212-2018 · May 17, 2017 · Terminated
  PENTARAY NAV High-Density Mapping Catheter.
• Z-1590-2016 · Apr 14, 2016 · Terminated
  Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is int
• Z-1176-2014 · Feb 20, 2014 · Terminated
  PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster