Generic Name: (1) Cardiovascular Catheter For Ablation (2) General-purpose Cryosurgical Unit Trade Name: (1) Polarx Cryoablation Catheter (2) Smartfreeze Cryo Console
Recall Summary Boston Scientific is recalling POLARx cryoablation catheters and disabling Smartfreeze cryoconsole machines used in heart rhythm procedures. The recall was initiated after three cases of atrial-esophageal fistula (a serious complication where an abnormal connection forms between the heart chamber and esophagus) were reported internationally, though no cases have been reported in Japan. Alternative treatment technologies with better safety profiles are now widely available.
- Recalling firm
- Name of Manufacturer and Distributor: Boston Scientific Japan K.K. Address of Manufacturer and Distributor: Nakano Central Park South, 4-10-2 Nakano, Nakano-ku, Tokyo Type of License: Class I...
- Product
- Lot: (1)POLARx 冷凍アブレーションカテーテル 品番：M004CRBS2010 ロット： 33782457 33784257 33788007 33800799 33803128 33805019 33808621 33808622 33808623 33808624 33808626 33815806 33819755 33819756 33821968 33839625 33839626 33925056 34040321 34040322 34051024 34051712 34051713 34054698 34074641 34081260 34081891 34081892 34081893 34081894 34081895 34081896 34098095 34098096 34100754 34107106 34108375 34114084 34114934 34116108 34122758 34123342 34125234 34128543 34128544 34174983 34178190 34182487 34186018 34186019 34209346 34211924 34212618 34216585 34217804 34220089 34227203 34227578 34309841 34309842...
- Reason
- In October 2024, we provided information regarding the potential risk of atrioesophageal fistula associated with the “POLARx Cryoablation Catheter” and the “SMARTFREEZE Cryo Console” (hereinafter collectively referred to as “the System”). As a result of ongoing post-market surveillance of the System, three new cases of atrioesophageal fistula have been confirmed overseas in recent months. Following a detailed evaluation of the atrioesophageal fistula cases, no product performance issues were identified in the components of this system; however, at this time, new alternative treatment...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Recall date
- 2026-04-09
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/1cf984fc-fa16-4a34-88d9-8156154aac4b