Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-01J0, 185 cm, J-Tip, Single Pack. Catalog No. 38951-01J2, 185

FDA device recall Z-1218-06 · posted 2006-07-12 · Terminated

Recall details

Recalling firm

Boston Scientific

Reason for recall

Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off.

Action taken

On May 30, 2006, Boston Scientific notified customers of the IQ Guide Wire manufactured from February 3, 2006, through March 15, 2006. BSC requested a reply whether or not they still have product in their institution. Replacements will be issued for returned product. UPDATE: A second recall notification was sent to affected customers 07/07/06. This second notification included Inner Pouch Number (UPN) and Inner Pouch Lot/Batch #.

Root cause

Other

Status

Terminated

Product code

DQX

Quantity affected

1455 units total

Distribution

Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.

Date initiated

2006-05-30

Date posted

2006-07-12

Date terminated

2007-06-28

Location

Maple Grove, MN