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Terminated

Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced.

FDA Recall Z-1470-2009 · Posted 2009-06-18

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2009-03-11
Date Terminated2012-01-07
Product QuantityU.S. and U.S. territories: 22,728; OUS: 11,308

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

Firm Action

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

Distribution Pattern

Worldwide Distribution -- USA, United Arab Emirates, Dutch Antilles, Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Egypt, Spain, Finland, France, Great Britain, India, Indonesia, Ireland, Iraq, Italy, Jamaica, Japan, Kuwait, Sri Lanka, Libya, Netherlands, Norway, Poland, Puerto Rico, Qatar, Saudi Arabia, Sweden, Singapore, Syria, Turkey and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERScimed Life Systems, Inc. · 1998-08-18K974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERScimed Life Systems, Inc. · 1998-02-19K970823SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETERScimed Life Systems, Inc. · 1997-06-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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