510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1213-06

Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No...

Boston Scientific Corporation / initiated 2006-05-30 / Terminated
FDA source (opens on fda.gov)

Boston Scientific began a recall of Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1213-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
Product code
DQX Wire, Guide, Catheter
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.
FDA root cause
Other
Action
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 #.
Quantity in commerce
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.
Product codes and lots
Catalog No. 38950-010 with Box Lot/Batch No. AND Inner-Pouch Lot/Batch No.: 8396722/8374308, 8397332/8374309, 8411208/8387184, 8414011/8398030, 8414321/8391628, 8414625/8394866, 8414627/8395261, 8414958/8391724, 8423202/8404318, 8423636/8398031, 8428184/8408727, 8430959/8404322, 8433309/8408726, 8433399/8403092, 8435627/8415782, 8437126/8415778, 8438614/8413997, 8439171/8419527, 8439179/8419528, 8440181/8419529.   Catalog No. 38950-012 with Box Lot No. AND Inner-Pouch Lot/Batch No.: 8396863/8374308, 8397333/8374309, 8411209/8387184, 8414012/8398030, 8414319/8391628, 8414626/8394866, 8414628/8395261, 8414957/8391724, 8423343/8404318, 8423638/8398031, 8428185/8408727, 8430961/8404322, 8433308/8408726, 84333938403093, 8433400/4803092, 8435628/8415782, 8437125/8415778, 8438615/8413997, 8439172/8419527, 8439180/8419528, 8440182/8419529.