Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascula

FDA device recall Z-1470-2009 · posted 2009-06-18 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. There have been 41 complaints in the US as

Action taken

Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated March 11, 2009. The letter was addressed to Risk Manager/Field Action Contacts describing the problem including instructions for affected device handling and a request to return the enclosed Reply Verification Tracking Form. Further questions can be addressed to Boston Scientific at 763-494-1634.

Root cause

Process change control

Status

Terminated

Product code

DQY

Quantity affected

U.S. and U.S. territories: 22,728; OUS: 11,308

Distribution

Worldwide Distribution -- USA, United Arab Emirates, Dutch Antilles, Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Egypt, Spain, Finland,

Date initiated

2009-03-11

Date posted

2009-06-18

Date terminated

2012-01-07

Location

Maple Grove, MN

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