Boston Scientific Target iLab Utrasound Imaging System, software controlled Imaging Catheter. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iLab Utrasound Imaging System, software controlled Imaging Catheter.
Brand
Boston Scientific Target
Lot Codes / Batch Numbers
Model Numbers M0004EPiL120CART0, serial number 4037, H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037, H749iLab120CARTD0, serial number 4064, H749iLab120CARTR0, serial number 4022, H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
Products Sold
Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
Boston Scientific Target is recalling iLab Utrasound Imaging System, software controlled Imaging Catheter. due to Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intrac. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only)
Recommended Action
Per FDA guidance
The firm initiated recall actions on March 6, 2006. On March 21, 2006, the firm issued notification letters to all appropriate personnel at hospitals and user facilities to inform them of actions taken by Boston Scientific to remediate any risks.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026