Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
- Recall Initiated
- May 1, 2007
- Posted
- August 26, 2008
- Terminated
- September 10, 2008
- Recall Number
- Z-2165-2008
- Quantity
- 24 Units
- Firm Location
- Scientific Place Natick, MA
Reason for Recall
The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
Distribution
International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.
Lot / Code Info
Lot 9565194, Exp April 2010.
Root Cause
Nonconforming Material/Component
Action Taken
Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required" letter dated May 11, 2007. The letter addressed to Risk mangers, described the issue and product. The letter requested the immediate discontinued use of and segregation of recalled product, A Reply Verification Tracking Form was requested to be completed and returned.
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