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Terminated

Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.

FDA Recall Z-0935-2008 · Posted 2008-01-31

Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeDQO
Date Initiated2007-11-20
Date Terminated2008-10-23
Product Quantity211 single units

Reason for Recall

Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.

Firm Action

The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000956MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERSBoston Scientific Scimed, Inc. · 2000-04-21K992123SCIMED IMPULSE ANGIOGRAPHIC CATHETERSBoston Scientific Scimed, Inc. · 1999-08-23K974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSScimed Life Systems, Inc. · 1998-02-23K964859SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSScimed Life Systems, Inc. · 1997-02-10

Official Source

View FDA Recall →

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

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