Sniper Elite Model-Or-E3872XX Series

• • Terminated Z-0623-2010 FDA Unclassified (pre-2012) ·initiated 25 Aug 2009

  Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).

• 41 recalls, same reason

  • Terminated Z-1272-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1278-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1280-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1297-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1300-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1270-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1284-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1285-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1292-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1290-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1283-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1299-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1304-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1307-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1288-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1296-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1271-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1281-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1295-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1274-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1269-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1303-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1273-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1275-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1277-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1301-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1305-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1294-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1289-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1267-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1293-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1268-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1291-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1276-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1286-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1298-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1302-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1287-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1306-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1282-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009
  • Terminated Z-1279-2009 FDA Unclassified (pre-2012) ·initiated 26 Feb 2009

  Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.

• 10 recalls, same reason

  • Terminated Z-0891-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0883-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0888-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0889-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0885-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0890-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0882-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0886-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0884-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007
  • Terminated Z-0887-2008 FDA Unclassified (pre-2012) ·initiated 19 Nov 2007

  Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.

510(k) Number

K011905 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K021452 Active Cleared 1 Aug 2002

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  FDA 510(k) K010297 Active Cleared 16 Feb 2001

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